Rotator Cuff Tear Arthropathy
Conditions
Brief summary
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
Detailed description
Patients will be randomized into two cohorts: 1. Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. 2. Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria. Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be assessed at every visit. Functional shoulder outcomes including shoulder range of motion and the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be completed at the preoperative visit and final follow-up visit only. We will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery
Interventions
DRUGIbuprofen
Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.
DRUGPlacebo
Pharmacy formulated placebo
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years or older * Patients that undergo arthroscopic rotator cuff repair only
Exclusion criteria
* Patients less than 18 years of age, pregnant, are incarcerated. Women who are not post-menopause are screened for pregnancy preoperatively with a urine test per our UCSF Orthopaedic Institute preoperative guidelines. * Patients who are unable to and not willing to comply with the study protocol and follow-up visits * Patients with a history of prior rotator cuff repair * Patients with rotator cuff tears that require open repair * Patients with an allergy to ibuprofen or anti-inflammatory medications * Patients with a medical chart record or those who report a history of upper gastroenterology bleed or gastric ulcers * Patients who are currently on warfarin, enoxaparin, heparin, or a factor Xa inhibiting anti-coagulation medication * Patients with a known past medical history of chronic kidney disease, history of kidney transplant, or eGFR \< 60 mL/min per 1.73m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo | 1 week post operative | pain control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Functional Shoulder Outcome Score: DASH | preop, 1 year postop | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome |
| Assessment of Functional Shoulder Outcome Score: SF-12 | Preop, 1 year post/op | The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. |
| Post Operative Pain Score (Visual Analog Scale) | 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op | Pain scale from 0 (no pain) - 10 (worst) |
| Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op | American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities). |
| Range of Motion - Abduction | preoperative, 6 weeks, 3 months, 6 months, 1 year | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees |
| Range of Motion - External Rotation at Side | preoperative, 6 weeks, 3 months, 6 months, 1 year | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees |
| Range of Motion - External Rotation at 90 Degrees Abduction | preoperative, 6 weeks, 3 months, 6 months, 1 year | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees |
| Range of Motion - Forward Flexion | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator. | 51 |
| Placebo Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
Placebo: Pharmacy formulated placebo | 50 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Placebo | Ibuprofen |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 12.1 | 56.9 years STANDARD_DEVIATION 13.8 | 57.7 years STANDARD_DEVIATION 10.8 |
| Biceps Tenotomy | 19 Participants | 13 Participants | 6 Participants |
| Hand Dominance Data missing | 4 Participants | 1 Participants | 3 Participants |
| Hand Dominance Left | 6 Participants | 4 Participants | 2 Participants |
| Hand Dominance Right | 91 Participants | 45 Participants | 46 Participants |
| Preoperative NSAID Use Celecoxib | 0 Participants | 0 Participants | 0 Participants |
| Preoperative NSAID Use Ibuprofen | 17 Participants | 8 Participants | 9 Participants |
| Preoperative NSAID Use Naproxen | 6 Participants | 3 Participants | 3 Participants |
| Preoperative NSAID Use Other | 2 Participants | 1 Participants | 1 Participants |
| Preoperative Opioid Use Hydromorphone | 0 Participants | 0 Participants | 0 Participants |
| Preoperative Opioid Use Morphine | 0 Participants | 0 Participants | 0 Participants |
| Preoperative Opioid Use Norco | 5 Participants | 2 Participants | 3 Participants |
| Preoperative Opioid Use Oxycodone | 1 Participants | 0 Participants | 1 Participants |
| Preoperative Opioid Use Percocet | 0 Participants | 0 Participants | 0 Participants |
| Prior Shoulder Cortisone Injection | 30 Participants | 15 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Black | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 66 Participants | 34 Participants | 32 Participants |
| Region of Enrollment United States | 101 participants | 50 participants | 51 participants |
| Repair Technique Data missing | 8 Participants | 3 Participants | 5 Participants |
| Repair Technique Double Row | 27 Participants | 14 Participants | 13 Participants |
| Repair Technique Single Row | 66 Participants | 33 Participants | 33 Participants |
| Sex: Female, Male Female | 43 Participants | 21 Participants | 22 Participants |
| Sex: Female, Male Male | 58 Participants | 29 Participants | 29 Participants |
| Shoulder Involved Left | 43 Participants | 19 Participants | 24 Participants |
| Shoulder Involved Right | 58 Participants | 31 Participants | 27 Participants |
| Size of Rotator Cuff Tear Data missing | 1 Participants | 0 Participants | 1 Participants |
| Size of Rotator Cuff Tear Large | 9 Participants | 6 Participants | 3 Participants |
| Size of Rotator Cuff Tear Massive | 4 Participants | 1 Participants | 3 Participants |
| Size of Rotator Cuff Tear Medium | 47 Participants | 24 Participants | 23 Participants |
| Size of Rotator Cuff Tear Small | 40 Participants | 19 Participants | 21 Participants |
| Surgical Side Data missing | 4 Participants | 1 Participants | 3 Participants |
| Surgical Side Dominant | 54 Participants | 30 Participants | 24 Participants |
| Surgical Side Non-Dominant | 43 Participants | 19 Participants | 24 Participants |
| Tendons Torn Infraspinatus | 17 Participants | 5 Participants | 12 Participants |
| Tendons Torn Subscapularis | 52 Participants | 27 Participants | 25 Participants |
| Tendons Torn Supraspinatus | 82 Participants | 42 Participants | 40 Participants |
| Tendons Torn Teres Minor | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 54 |
| other Total, other adverse events | 0 / 56 | 0 / 54 |
| serious Total, serious adverse events | 0 / 56 | 0 / 54 |
Outcome results
Primary
Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo
pain control
Time frame: 1 week post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo | 168.3 morphine milligram equivalents | Standard Deviation 96 |
| Placebo | Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo | 210.9 morphine milligram equivalents | Standard Deviation 104 |
Secondary
Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES)
American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities).
Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 1 year | 93.4 score on a scale | Standard Deviation 8.1 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | Preoperative | 57.8 score on a scale | Standard Deviation 21.1 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 6 weeks | 54.6 score on a scale | Standard Deviation 15.5 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 3 months | 69.4 score on a scale | Standard Deviation 18.2 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 6 months | 86.1 score on a scale | Standard Deviation 12.1 |
| Placebo | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 6 months | 78.1 score on a scale | Standard Deviation 17.4 |
| Placebo | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 3 months | 69.3 score on a scale | Standard Deviation 15.9 |
| Placebo | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | Preoperative | 56.2 score on a scale | Standard Deviation 20.7 |
| Placebo | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 1 year | 90.9 score on a scale | Standard Deviation 11.2 |
| Placebo | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | 6 weeks | 54 score on a scale | Standard Deviation 14.7 |
Secondary
Assessment of Functional Shoulder Outcome Score: DASH
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome
Time frame: preop, 1 year postop
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: DASH | preoperative | 62.6 score on a scale | Standard Deviation 20.4 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: DASH | 1 year | 31.9 score on a scale | Standard Deviation 8.8 |
| Placebo | Assessment of Functional Shoulder Outcome Score: DASH | preoperative | 62.3 score on a scale | Standard Deviation 18.1 |
| Placebo | Assessment of Functional Shoulder Outcome Score: DASH | 1 year | 36.4 score on a scale | Standard Deviation 13.6 |
Secondary
Assessment of Functional Shoulder Outcome Score: SF-12
The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: Preop, 1 year post/op
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: SF-12 | SF-12 PCS preoperative | 42.3 score on a scale | Standard Deviation 10.3 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: SF-12 | Sf-12 MCS 1 year | 53 score on a scale | Standard Deviation 9.5 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: SF-12 | SF-12 PCS 1 year | 52.5 score on a scale | Standard Deviation 5.8 |
| Ibuprofen | Assessment of Functional Shoulder Outcome Score: SF-12 | SF-12 MCS preoperative | 51.2 score on a scale | Standard Deviation 9.5 |
| Placebo | Assessment of Functional Shoulder Outcome Score: SF-12 | SF-12 PCS preoperative | 40.3 score on a scale | Standard Deviation 9.4 |
| Placebo | Assessment of Functional Shoulder Outcome Score: SF-12 | SF-12 MCS preoperative | 50.1 score on a scale | Standard Deviation 11.7 |
| Placebo | Assessment of Functional Shoulder Outcome Score: SF-12 | SF-12 PCS 1 year | 49.4 score on a scale | Standard Deviation 9.6 |
| Placebo | Assessment of Functional Shoulder Outcome Score: SF-12 | Sf-12 MCS 1 year | 51.3 score on a scale | Standard Deviation 11.8 |
Secondary
Post Operative Pain Score (Visual Analog Scale)
Pain scale from 0 (no pain) - 10 (worst)
Time frame: 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Post Operative Pain Score (Visual Analog Scale) | 6 weeks | 2.1 score on a scale | Standard Deviation 2 |
| Ibuprofen | Post Operative Pain Score (Visual Analog Scale) | 3 months | 1.8 score on a scale | Standard Deviation 1.9 |
| Ibuprofen | Post Operative Pain Score (Visual Analog Scale) | 6 months | 0.9 score on a scale | Standard Deviation 1.1 |
| Ibuprofen | Post Operative Pain Score (Visual Analog Scale) | 1 year | 0.4 score on a scale | Standard Deviation 0.8 |
| Placebo | Post Operative Pain Score (Visual Analog Scale) | 1 year | 0.7 score on a scale | Standard Deviation 1.2 |
| Placebo | Post Operative Pain Score (Visual Analog Scale) | 6 weeks | 2.5 score on a scale | Standard Deviation 2.1 |
| Placebo | Post Operative Pain Score (Visual Analog Scale) | 6 months | 1.3 score on a scale | Standard Deviation 1.5 |
| Placebo | Post Operative Pain Score (Visual Analog Scale) | 3 months | 1.8 score on a scale | Standard Deviation 1.9 |
Secondary
Range of Motion - Abduction
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Range of Motion - Abduction | 6 weeks | 73 degrees | Standard Deviation 25 |
| Ibuprofen | Range of Motion - Abduction | 6 months | 164 degrees | Standard Deviation 21 |
| Ibuprofen | Range of Motion - Abduction | 3 months | 131 degrees | Standard Deviation 30 |
| Ibuprofen | Range of Motion - Abduction | 1 year | 164 degrees | Standard Deviation 24 |
| Ibuprofen | Range of Motion - Abduction | Preoperative | 133 degrees | Standard Deviation 41 |
| Placebo | Range of Motion - Abduction | 1 year | 161.8 degrees | Standard Deviation 20 |
| Placebo | Range of Motion - Abduction | Preoperative | 125.2 degrees | Standard Deviation 46 |
| Placebo | Range of Motion - Abduction | 6 weeks | 76.7 degrees | Standard Deviation 37 |
| Placebo | Range of Motion - Abduction | 3 months | 132.8 degrees | Standard Deviation 39 |
| Placebo | Range of Motion - Abduction | 6 months | 151.6 degrees | Standard Deviation 33 |
Secondary
Range of Motion - External Rotation at 90 Degrees Abduction
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Range of Motion - External Rotation at 90 Degrees Abduction | Preoperative | 68 degrees | Standard Deviation 24 |
| Ibuprofen | Range of Motion - External Rotation at 90 Degrees Abduction | 6 weeks | 42 degrees | Standard Deviation 18 |
| Ibuprofen | Range of Motion - External Rotation at 90 Degrees Abduction | 3 months | 69 degrees | Standard Deviation 16 |
| Ibuprofen | Range of Motion - External Rotation at 90 Degrees Abduction | 6 months | 78 degrees | Standard Deviation 13 |
| Ibuprofen | Range of Motion - External Rotation at 90 Degrees Abduction | 1 year | 83 degrees | Standard Deviation 12 |
| Placebo | Range of Motion - External Rotation at 90 Degrees Abduction | 6 months | 76 degrees | Standard Deviation 14 |
| Placebo | Range of Motion - External Rotation at 90 Degrees Abduction | 3 months | 68 degrees | Standard Deviation 17 |
| Placebo | Range of Motion - External Rotation at 90 Degrees Abduction | Preoperative | 68 degrees | Standard Deviation 29 |
| Placebo | Range of Motion - External Rotation at 90 Degrees Abduction | 1 year | 81 degrees | Standard Deviation 12 |
| Placebo | Range of Motion - External Rotation at 90 Degrees Abduction | 6 weeks | 42 degrees | Standard Deviation 26 |
Secondary
Range of Motion - External Rotation at Side
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Time frame: preoperative, 6 weeks, 3 months, 6 months, 1 year
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Range of Motion - External Rotation at Side | 1 year | 67 degrees | Standard Deviation 16 |
| Ibuprofen | Range of Motion - External Rotation at Side | preoperative | 58 degrees | Standard Deviation 18 |
| Ibuprofen | Range of Motion - External Rotation at Side | 6 weeks | 35 degrees | Standard Deviation 13.4 |
| Ibuprofen | Range of Motion - External Rotation at Side | 3 months | 51 degrees | Standard Deviation 16 |
| Ibuprofen | Range of Motion - External Rotation at Side | 6 months | 62 degrees | Standard Deviation 14 |
| Placebo | Range of Motion - External Rotation at Side | 6 months | 57 degrees | Standard Deviation 18 |
| Placebo | Range of Motion - External Rotation at Side | 3 months | 56 degrees | Standard Deviation 17 |
| Placebo | Range of Motion - External Rotation at Side | preoperative | 59.7 degrees | Standard Deviation 18 |
| Placebo | Range of Motion - External Rotation at Side | 1 year | 65 degrees | Standard Deviation 17 |
| Placebo | Range of Motion - External Rotation at Side | 6 weeks | 36 degrees | Standard Deviation 17 |
Secondary
Range of Motion - Forward Flexion
Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees
Time frame: Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op
Population: The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen | Range of Motion - Forward Flexion | 6 weeks | 92 degrees | Standard Deviation 29 |
| Ibuprofen | Range of Motion - Forward Flexion | 6 months | 162 degrees | Standard Deviation 14 |
| Ibuprofen | Range of Motion - Forward Flexion | 3 months | 142 degrees | Standard Deviation 19 |
| Ibuprofen | Range of Motion - Forward Flexion | 1 year | 168 degrees | Standard Deviation 16 |
| Ibuprofen | Range of Motion - Forward Flexion | Preoperative | 137 degrees | Standard Deviation 39 |
| Placebo | Range of Motion - Forward Flexion | 1 year | 164 degrees | Standard Deviation 17 |
| Placebo | Range of Motion - Forward Flexion | Preoperative | 133 degrees | Standard Deviation 40 |
| Placebo | Range of Motion - Forward Flexion | 6 weeks | 96 degrees | Standard Deviation 35 |
| Placebo | Range of Motion - Forward Flexion | 3 months | 138 degrees | Standard Deviation 30 |
| Placebo | Range of Motion - Forward Flexion | 6 months | 153 degrees | Standard Deviation 22 |