Arthroplasty, Replacement, Hip
Conditions
Brief summary
Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.
Interventions
DEVICELFIT™ Femoral Heads With X3® Insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned. 2. Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger. 3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant 4. Patient is a male or non-pregnant female age 18 years or older at time of enrollment. 5. Patient has signed an IRB approved, study specific Informed Patient Consent Form. 6. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
1. Patient has an active infection within the affected hip joint. 2. Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint. 3. Patient has a Body Mass Index (BMI) ≥ 40. 4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 5. Patient is diagnosed with systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (i.e. Paget's disease, renal osteodystrophy, rheumatoid arthritis). 6. Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day. 7. Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule. 8. Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear Wear Rate | 5 Years Post-Surgery | Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period. . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits | preop, 1, 3, and 5 Years | This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it. Pain: 1. None or ignores it = 44 points 2. Slight, occasional, no compromise in activities = 40 points 3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points 4. Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points 5. Marked pain, serious limitation of activities = 10 points 6. Totally disabled, crippled, pain in bed, bedridden = 0 points |
| Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. | preoperative, 1, 3, and 5 Years | This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome. Flexion: 0-45 degrees x 1.0 index value = max 45 points 45-90 degrees x 0.6 index = max 27 points 90-110 degrees x 0.3 index = max 6 points 110-130 degrees = max 0 points Abduction: 0-15 degrees x 0.8 index = max 12 points 15-20 degrees x 0.3 index = max 1.5 points 20-45 degrees x 0 index = max 0 points External Rotation in extension: 0-15 degrees x 0.4 index = max 6 points Over 15 degrees = max 0 points Internal Rotation in extension: Any = max 0 points Adduction: 0-15 degrees x 0.2 index = max 3 points Over 15 degrees - max 0 points To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05. |
| Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | preop, 1, 3, and 5 Years | The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | preoperative, 1, 3, and 5 years | The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor |
| Number of Hips That Dislocated | 3 and 5 years | The number of hips that experienced a hip dislocation. |
| Number of Hips Evaluated as Radiographically Unstable | 1, 3, 5 years | Radiographic instability is defined as having any of the following findings on x-ray: * Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component * Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component * Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component * Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm. |
| Percentage of Cases That Did Not Have Any Component Revised | 5 years | A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner. The 97.42% estimate is obtained by Kaplan-Meier method. |
| Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | preoperative, 1, 3, and 5 Years | The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
Countries
United States
Participant flow
Pre-assignment details
89 patients/96 hips - 15 patients/18 hips censored = 74 patients/78 hips
Participants by arm
| Arm | Count |
|---|---|
| LFIT™Femoral Heads With X3® Insert LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 5 year not evaluable/missed | 21 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Revision | 2 |
| Overall Study | Terminated | 14 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | LFIT™Femoral Heads With X3® Insert |
|---|---|
| Age, Continuous | 61.48 years STANDARD_DEVIATION 10.37 |
| Region of Enrollment United States | 74 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 78 | 0 / 74 |
| serious Total, serious adverse events | 2 / 78 | 2 / 74 |
Outcome results
Primary
Linear Wear Rate
Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period. .
Time frame: 5 Years Post-Surgery
Population: Participants/hips with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Linear Wear Rate | 0.008 mm/year | Standard Deviation 0.057 |
90% CI: [-0.0107, 0.0267]
Secondary
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Time frame: preoperative, 1, 3, and 5 years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score preoperative | 51.03 units on a scale | Standard Deviation 11.25 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS 1 year | 94.14 units on a scale | Standard Deviation 9.45 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS 3 years | 97.98 units on a scale | Standard Deviation 4.51 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS 5 years | 97.59 units on a scale | Standard Deviation 6.07 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits
This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it. Pain: 1. None or ignores it = 44 points 2. Slight, occasional, no compromise in activities = 40 points 3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points 4. Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points 5. Marked pain, serious limitation of activities = 10 points 6. Totally disabled, crippled, pain in bed, bedridden = 0 points
Time frame: preop, 1, 3, and 5 Years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits | Mean HHS Pain score preoperative | 15.77 units on a scale | Standard Deviation 5.23 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits | Mean HHS Pain score 1 year | 41.36 units on a scale | Standard Deviation 5.14 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits | Mean HHS Pain score 3 years | 43.39 units on a scale | Standard Deviation 2.24 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits | Mean HHS Pain score 5 years | 42.89 units on a scale | Standard Deviation 4.48 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.
This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome. Flexion: 0-45 degrees x 1.0 index value = max 45 points 45-90 degrees x 0.6 index = max 27 points 90-110 degrees x 0.3 index = max 6 points 110-130 degrees = max 0 points Abduction: 0-15 degrees x 0.8 index = max 12 points 15-20 degrees x 0.3 index = max 1.5 points 20-45 degrees x 0 index = max 0 points External Rotation in extension: 0-15 degrees x 0.4 index = max 6 points Over 15 degrees = max 0 points Internal Rotation in extension: Any = max 0 points Adduction: 0-15 degrees x 0.2 index = max 3 points Over 15 degrees - max 0 points To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05.
Time frame: preoperative, 1, 3, and 5 Years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.~Cases at 1 and 5 years all had a score of 5, therefore there is zero standard deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. | HHS ROM preoperative | 4.05 units on a scale | Standard Deviation 0.82 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. | HHS ROM 1 year | 5.00 units on a scale | Standard Deviation 0 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. | HHS ROM 3 years | 4.98 units on a scale | Standard Deviation 0.14 |
| LFIT™Femoral Heads With X3® Insert | Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. | HHS ROM 5 years | 5.00 units on a scale | Standard Deviation 0 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: preoperative, 1, 3, and 5 Years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS Preoperative | 9.41 units on a scale | Standard Deviation 2.93 |
| LFIT™Femoral Heads With X3® Insert | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 1 year | 11.76 units on a scale | Standard Deviation 3.05 |
| LFIT™Femoral Heads With X3® Insert | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 3 years | 12.56 units on a scale | Standard Deviation 3.11 |
| LFIT™Femoral Heads With X3® Insert | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 5 years | 12.33 units on a scale | Standard Deviation 2.69 |
p-value: <0.0001t-test, 2 sided
p-value: 0.0006t-test, 2 sided
Secondary
Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.
The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: preop, 1, 3, and 5 Years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 physical component score preoperative | 34.8 units on a scale | Standard Deviation 9.47 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 physical component score 1 year | 49.93 units on a scale | Standard Deviation 9.39 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 physical component score 3 years | 52.51 units on a scale | Standard Deviation 7 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 physical component score 5 years | 50.35 units on a scale | Standard Deviation 9.89 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 mental component score preoperative | 50.75 units on a scale | Standard Deviation 12.56 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 mental component score 1 year | 55.63 units on a scale | Standard Deviation 7.47 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 mental component score 3 years | 55.25 units on a scale | Standard Deviation 8.91 |
| LFIT™Femoral Heads With X3® Insert | Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | SF-12 mental component score 5 years | 55.92 units on a scale | Standard Deviation 6.71 |
p-value: <0.0001t-test, 2 sided
p-value: 0.0394t-test, 2 sided
p-value: 0.4974t-test, 2 sided
p-value: 0.677t-test, 2 sided
Secondary
Number of Hips Evaluated as Radiographically Unstable
Radiographic instability is defined as having any of the following findings on x-ray: * Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component * Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component * Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component * Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm.
Time frame: 1, 3, 5 years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 1 year population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Number of Hips Evaluated as Radiographically Unstable | Radiographically Unstable Hips 1 year | 0 hips |
| LFIT™Femoral Heads With X3® Insert | Number of Hips Evaluated as Radiographically Unstable | Radiographically Unstable Hips 3 years | 0 hips |
| LFIT™Femoral Heads With X3® Insert | Number of Hips Evaluated as Radiographically Unstable | Radiographically Unstable Hips 5 years | 0 hips |
Secondary
Number of Hips That Dislocated
The number of hips that experienced a hip dislocation.
Time frame: 3 and 5 years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the 3 year population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Number of Hips That Dislocated | Hip dislocations 3 years | 0 hips |
| LFIT™Femoral Heads With X3® Insert | Number of Hips That Dislocated | Hip dislocations 5 years | 0 hips |
Secondary
Percentage of Cases That Did Not Have Any Component Revised
A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner. The 97.42% estimate is obtained by Kaplan-Meier method.
Time frame: 5 years
Population: Participants/hips with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LFIT™Femoral Heads With X3® Insert | Percentage of Cases That Did Not Have Any Component Revised | 97.42 percentage of hips |