Rupture of Anterior Cruciate Ligament
Conditions
Keywords
muscle atrophy, growth hormone, ACL tear
Brief summary
Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after patients return to full activity and can place them at considerable risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic interventions to prevent muscle atrophy is needed to advance the care of patients who suffer from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an important role in promoting muscle growth and protecting muscle from atrophy. While GH therapy has shown promise in protecting immobilized muscle from various models of disuse atrophy, it remains unknown whether GH can help to restore strength and protect against the loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe return to play of patients that suffer ACL tears, and help to prevent the long-term OA and reduction in quality of life that occur after these traumatic knee injuries.
Interventions
DRUGSomatropin
GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.
DRUGPlacebo
A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Sponsors
Hospital for Special Surgery, New York
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Males between the ages of 18 and 35 * Have acute unilateral complete ACL tears with or without bucket handle medial meniscus tears that occurred within the past 6 months * Consent to undergo an ACL reconstruction by an orthopaedic surgeon using a patellar tendon or hamstring autograft * Will be performing supervised post-operative rehabilitation at UMHS MedSport at Dominos Farms
Exclusion criteria
* Patients who are undergoing a revision ACL reconstruction * Had a previous injury to the involved knee * Have an allergy to recombinant GH * Have a BMI\<20 or \>35 * Have a growth disorder of bones or connective tissue, type 1 diabetes mellitus, type 2 diabetes mellitus, or who have a history of carpal tunnel syndrome, trigger finger, myopathy, cancer, endocrine disorder, hypertension or rheumatologic disorder. * Systolic blood pressure \>140mm Hg or diastolic blood pressure \>90mm Hg, or with resting heart rate \>110 BPM or \<40 BPM at screening. * Additionally, because GH is currently listed as a banned substance by the World Anti-Doping Agency (WADA), National Collegiate Athletics Association (NCAA) and most professional sports agencies, we will exclude patients who are current collegiate, professional or elite athletes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op | at 26 wks post-op | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normative Isokinetic Flexion (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op | at 26 weeks post-op | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Normative Isometric Extension (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Normative Isometric Extension (Nm) at 26 Weeks Post-op | at 26 weeks post-op | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Normative Isometric Flexion (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Normative Isometric Flexion (Nm) at 26 Weeks Post-op | at 26 weeks post-op | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isokinetic Extension (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isokinetic Extension (Nm) at 26 wk Post-op | at 26 wk post-op | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op | at 26 weeks post-op | Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isometric Extension (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isometric Extension (Nm) at 26 Weeks Post-op | at 26 weeks post-op | Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isometric Flexion (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used. |
| Absolute Isometric Flexion (Nm) at 26 Weeks Post-op | at 26 weeks post-op | Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used. |
| VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline) | at pre-op (baseline) | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59. |
| VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op | at 26 weeks post-op | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59. |
| VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline) | at pre-op (baseline) | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47. |
| VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op | at 26 weeks post-op | The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47. |
| International Knee Document Committee (IKDC) at Pre-op (Baseline) | at pre-op (baseline) | The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function. |
| International Knee Documentation Committee (IKDC) up to 26 wk Post-op | up to 26 wk post-op | The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function. |
| The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op | at 26 weeks post-op | KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline) | at pre-op (baseline) | KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline) | at pre-op (baseline) | KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op | at 26 weeks post-op | KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline) | at pre-op (baseline) | KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op | at 26 weeks post-op | KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op | at 26 weeks post-op | KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. |
| KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline) | at pre-op (baseline) | KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. |
| KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op | at 26 weeks post-op | KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline) | at pre-op (baseline) | KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures |
| Absolute Quadriceps Volume (L) at Pre-op (Baseline) | at pre-op (baseline) | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Absolute Quadricep Volume (L) at 26 Week Post-op | at 26 week post-op | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Absolute Hamstring Volume (L) at Pre-op (Baseline) | at pre-op (baseline) | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Absolute Hamstring Volume (L) at 26 Weeks Post-op | at 26 weeks post-op | Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Normalized Quadriceps Volume (L) at Pre-op (Baseline) | at pre-op (baseline) | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Normalized Quadriceps Volume (L) at 26 Weeks Post-op | at 26 weeks post-op | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Normalized Hamstring Volume (L) at Pre-op (Baseline) | at pre-op (baseline) | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
| Normative Isokinetic Extension (Nm) at Pre-op (Baseline) | at pre-op (baseline) | Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used. |
| Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op | Area under the curve between -1 and 5 weeks post-op | IGF1 was measured from serum using an IMMULITE 2000 system (Siemens). |
| Myostatin at -1 and 5 Weeks Post-op | Area under the curve between -1 and 5 weeks post-op | Myostatin was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. |
| MMP3 at -1 and 5 Weeks Post-op | Area under the curve between -1 and 5 weeks post-op | Matrix metalloproteinase-3 (MMP3) was measured from serum using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. |
| Hyaluronic Acid at -1 and 5 Weeks Post-op | Area under the curve between -1 and 5 weeks post-op | Hyaluronic acid was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations. |
| Normalized Hamstring Volume (L) at 26 Weeks Post-op | at 26 weeks post-op | Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS). |
Countries
United States
Participant flow
Recruitment details
Recruitment completed at the University of Michigan Sports Medicine Clinic
Participants by arm
| Arm | Count |
|---|---|
| Somatropin Somatropin of rDNA origin
Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period. | 10 |
| Placebo A placebo vehicle that contains somatropin diluent but no active hormone.
Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Somatropin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 9 Participants | 19 Participants |
| Isokinetic Knee Strength (Nm) Absolute Isokinetic Extension 60 dg/s Surgical | 127.9 Newton Meters STANDARD_DEVIATION 46.7 | 124.7 Newton Meters STANDARD_DEVIATION 43.1 | 126.3 Newton Meters STANDARD_DEVIATION 43.8 |
| Isokinetic Knee Strength (Nm) Absolute Isokinetic Flexion 60 dg/s Surgical | 74.7 Newton Meters STANDARD_DEVIATION 27.9 | 77.5 Newton Meters STANDARD_DEVIATION 11.4 | 76.0 Newton Meters STANDARD_DEVIATION 21.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 5 / 10 | 5 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op
Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 wks post-op
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op | 0.881 Nm |
| Placebo | Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op | 0.681 Nm |
Comparison: Mixed effect modelp-value: 0.0498Mixed Models Analysis
Secondary
Absolute Hamstring Volume (L) at 26 Weeks Post-op
Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at 26 weeks post-op
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Hamstring Volume (L) at 26 Weeks Post-op | 0.98 Liters |
| Placebo | Absolute Hamstring Volume (L) at 26 Weeks Post-op | 0.88 Liters |
p-value: 0.0122Mixed Models Analysis
Secondary
Absolute Hamstring Volume (L) at Pre-op (Baseline)
Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at pre-op (baseline)
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Hamstring Volume (L) at Pre-op (Baseline) | 1 Liters |
| Placebo | Absolute Hamstring Volume (L) at Pre-op (Baseline) | 0.88 Liters |
p-value: 0.0357Mixed Models Analysis
Secondary
Absolute Isokinetic Extension (Nm) at 26 wk Post-op
Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 wk post-op
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isokinetic Extension (Nm) at 26 wk Post-op | 140.1 Nm |
| Placebo | Absolute Isokinetic Extension (Nm) at 26 wk Post-op | 105.6 Nm |
p-value: 0.0564Mixed Models Analysis
Secondary
Absolute Isokinetic Extension (Nm) at Pre-op (Baseline)
Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isokinetic Extension (Nm) at Pre-op (Baseline) | 127.9 Nm |
| Placebo | Absolute Isokinetic Extension (Nm) at Pre-op (Baseline) | 124.7 Nm |
p-value: 0.8573Mixed Models Analysis
Secondary
Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op
Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op | 103.9 Nm |
| Placebo | Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op | 86.2 Nm |
p-value: 0.0901Mixed Models Analysis
Secondary
Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline)
Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline) | 74.7 Nm |
| Placebo | Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline) | 77.5 Nm |
p-value: 0.7883Mixed Models Analysis
Secondary
Absolute Isometric Extension (Nm) at 26 Weeks Post-op
Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isometric Extension (Nm) at 26 Weeks Post-op | 172.4 Nm |
| Placebo | Absolute Isometric Extension (Nm) at 26 Weeks Post-op | 140.3 Nm |
p-value: 0.161Mixed Models Analysis
Secondary
Absolute Isometric Extension (Nm) at Pre-op (Baseline)
Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isometric Extension (Nm) at Pre-op (Baseline) | 183.1 Nm |
| Placebo | Absolute Isometric Extension (Nm) at Pre-op (Baseline) | 172.1 Nm |
p-value: 0.6292Mixed Models Analysis
Secondary
Absolute Isometric Flexion (Nm) at 26 Weeks Post-op
Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isometric Flexion (Nm) at 26 Weeks Post-op | 84.6 Nm |
| Placebo | Absolute Isometric Flexion (Nm) at 26 Weeks Post-op | 88.1 Nm |
p-value: 0.7325Mixed Models Analysis
Secondary
Absolute Isometric Flexion (Nm) at Pre-op (Baseline)
Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Isometric Flexion (Nm) at Pre-op (Baseline) | 69.2 Nm |
| Placebo | Absolute Isometric Flexion (Nm) at Pre-op (Baseline) | 77.2 Nm |
p-value: 0.4437Mixed Models Analysis
Secondary
Absolute Quadriceps Volume (L) at Pre-op (Baseline)
Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at pre-op (baseline)
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Quadriceps Volume (L) at Pre-op (Baseline) | 2.48 Liters |
| Placebo | Absolute Quadriceps Volume (L) at Pre-op (Baseline) | 2.12 Liters |
p-value: 0.0509Mixed Models Analysis
Secondary
Absolute Quadricep Volume (L) at 26 Week Post-op
Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at 26 week post-op
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Absolute Quadricep Volume (L) at 26 Week Post-op | 2.27 Liters |
| Placebo | Absolute Quadricep Volume (L) at 26 Week Post-op | 2.12 Liters |
p-value: 0.1605Mixed Models Analysis
Secondary
Hyaluronic Acid at -1 and 5 Weeks Post-op
Hyaluronic acid was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations.
Time frame: Area under the curve between -1 and 5 weeks post-op
Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Hyaluronic Acid at -1 and 5 Weeks Post-op | 190.7 ng*days/mL |
| Placebo | Hyaluronic Acid at -1 and 5 Weeks Post-op | 193.6 ng*days/mL |
p-value: 0.8581Mixed Models Analysis
Secondary
Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op
IGF1 was measured from serum using an IMMULITE 2000 system (Siemens).
Time frame: Area under the curve between -1 and 5 weeks post-op
Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op | 22478 ng*days/mL |
| Placebo | Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op | 10626 ng*days/mL |
p-value: <0.0001Mixed Models Analysis
Secondary
International Knee Documentation Committee (IKDC) up to 26 wk Post-op
The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.
Time frame: up to 26 wk post-op
Population: A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | International Knee Documentation Committee (IKDC) up to 26 wk Post-op | 65 units on a scale |
| Placebo | International Knee Documentation Committee (IKDC) up to 26 wk Post-op | 67 units on a scale |
p-value: 0.5251Mixed Models Analysis
Secondary
International Knee Document Committee (IKDC) at Pre-op (Baseline)
The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.
Time frame: at pre-op (baseline)
Population: A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | International Knee Document Committee (IKDC) at Pre-op (Baseline) | 54.6 score on a scale |
| Placebo | International Knee Document Committee (IKDC) at Pre-op (Baseline) | 55.6 score on a scale |
p-value: 0.1331Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline)
KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline) | 88 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline) | 91 score on a scale |
p-value: 0.4852Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op
KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op | 91 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op | 92 score on a scale |
p-value: 0.7943Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline)
KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline) | 74 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline) | 83 score on a scale |
p-value: 0.0894Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op
KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op | 53 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op | 63 score on a scale |
p-value: 0.0673Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline)
KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline) | 33 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline) | 47 score on a scale |
p-value: 0.0185Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op
KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op | 67.5 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op | 72.2 score on a scale |
p-value: 0.6094Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline)
KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline) | 46.5 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline) | 55.6 score on a scale |
p-value: 0.3279Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op
KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op | 60 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op | 68 score on a scale |
p-value: 0.2802Mixed Models Analysis
Secondary
KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline)
KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline) | 53 score on a scale |
| Placebo | KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline) | 64 score on a scale |
p-value: 0.1064Mixed Models Analysis
Secondary
MMP3 at -1 and 5 Weeks Post-op
Matrix metalloproteinase-3 (MMP3) was measured from serum using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations.
Time frame: Area under the curve between -1 and 5 weeks post-op
Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | MMP3 at -1 and 5 Weeks Post-op | 1188 ng*days/mL |
| Placebo | MMP3 at -1 and 5 Weeks Post-op | 766 ng*days/mL |
p-value: 0.0208Mixed Models Analysis
Secondary
Myostatin at -1 and 5 Weeks Post-op
Myostatin was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations.
Time frame: Area under the curve between -1 and 5 weeks post-op
Population: Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Myostatin at -1 and 5 Weeks Post-op | 190.7 ng*days/mL |
| Placebo | Myostatin at -1 and 5 Weeks Post-op | 193.6 ng*days/mL |
p-value: 0.8581Mixed Models Analysis
Secondary
Normalized Hamstring Volume (L) at 26 Weeks Post-op
Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at 26 weeks post-op
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normalized Hamstring Volume (L) at 26 Weeks Post-op | 1.03 Liters |
| Placebo | Normalized Hamstring Volume (L) at 26 Weeks Post-op | 0.93 Liters |
p-value: 0.7507Mixed Models Analysis
Secondary
Normalized Hamstring Volume (L) at Pre-op (Baseline)
Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at pre-op (baseline)
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normalized Hamstring Volume (L) at Pre-op (Baseline) | 1.06 Liters |
| Placebo | Normalized Hamstring Volume (L) at Pre-op (Baseline) | 0.93 Liters |
p-value: 0.5022Mixed Models Analysis
Secondary
Normalized Quadriceps Volume (L) at 26 Weeks Post-op
Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at 26 weeks post-op
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normalized Quadriceps Volume (L) at 26 Weeks Post-op | 0.91 Liters |
| Placebo | Normalized Quadriceps Volume (L) at 26 Weeks Post-op | 0.85 Liters |
p-value: 0.6288Mixed Models Analysis
Secondary
Normalized Quadriceps Volume (L) at Pre-op (Baseline)
Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).
Time frame: at pre-op (baseline)
Population: Scans were performed on a total of 19 participant at three time points throughout the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normalized Quadriceps Volume (L) at Pre-op (Baseline) | 1 Liters |
| Placebo | Normalized Quadriceps Volume (L) at Pre-op (Baseline) | 0.85 Liters |
p-value: 0.5853Mixed Models Analysis
Secondary
Normative Isokinetic Extension (Nm) at Pre-op (Baseline)
Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isokinetic Extension (Nm) at Pre-op (Baseline) | 0.746 Nm |
| Placebo | Normative Isokinetic Extension (Nm) at Pre-op (Baseline) | 0.816 Nm |
p-value: 0.7024Mixed Models Analysis
Secondary
Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op
Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op | 1.068 Nm |
| Placebo | Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op | 1.028 Nm |
p-value: 0.6836Mixed Models Analysis
Secondary
Normative Isokinetic Flexion (Nm) at Pre-op (Baseline)
Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isokinetic Flexion (Nm) at Pre-op (Baseline) | 0.738 Nm |
| Placebo | Normative Isokinetic Flexion (Nm) at Pre-op (Baseline) | 0.92 Nm |
p-value: 0.135Mixed Models Analysis
Secondary
Normative Isometric Extension (Nm) at 26 Weeks Post-op
Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isometric Extension (Nm) at 26 Weeks Post-op | 0.718 Nm |
| Placebo | Normative Isometric Extension (Nm) at 26 Weeks Post-op | 0.633 Nm |
p-value: 0.1576Mixed Models Analysis
Secondary
Normative Isometric Extension (Nm) at Pre-op (Baseline)
Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isometric Extension (Nm) at Pre-op (Baseline) | 0.761 Nm |
| Placebo | Normative Isometric Extension (Nm) at Pre-op (Baseline) | 0.778 Nm |
p-value: 0.9271Mixed Models Analysis
Secondary
Normative Isometric Flexion (Nm) at 26 Weeks Post-op
Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isometric Flexion (Nm) at 26 Weeks Post-op | 1.017 Nm |
| Placebo | Normative Isometric Flexion (Nm) at 26 Weeks Post-op | 0.954 Nm |
p-value: 0.45Mixed Models Analysis
Secondary
Normative Isometric Flexion (Nm) at Pre-op (Baseline)
Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | Normative Isometric Flexion (Nm) at Pre-op (Baseline) | 0.771 Nm |
| Placebo | Normative Isometric Flexion (Nm) at Pre-op (Baseline) | 0.867 Nm |
p-value: 0.5586Mixed Models Analysis
Secondary
The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op
KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately. Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op | 98 score on a scale |
| Placebo | The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op | 98.0 score on a scale |
p-value: 0.1064Mixed Models Analysis
Secondary
VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op
The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op | 56.7 T-score |
| Placebo | VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op | 59.3 T-score |
p-value: 0.4965Mixed Models Analysis
Secondary
VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline)
The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline) | 54.6 T-score |
| Placebo | VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline) | 55.6 T-score |
p-value: 0.79Mixed Models Analysis
Secondary
VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op
The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.
Time frame: at 26 weeks post-op
Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op | 52.9 T-score |
| Placebo | VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op | 50.2 T-score |
p-value: 0.3332Mixed Models Analysis
Secondary
VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline)
The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.
Time frame: at pre-op (baseline)
Population: A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Somatropin | VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline) | 46.5 T-score |
| Placebo | VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline) | 45.1 T-score |
p-value: 0.6291Mixed Models Analysis