Non-inflammatory Degenerative Joint Disease
Conditions
Keywords
Hip arthroplasty, Acetabular cup, Ceramic-on-polyethylene
Brief summary
This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner. This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.
Detailed description
Total Hip Arthroplasty (THA) is the surgical reconstruction of the hip joint through replacement of the femoral head and the acetabular articulating surfaces with fixed prosthetic devices. The goals of THA are relief from pain, restoration of function, and correction of deformity. THA is one of the most common adult reconstructive procedures. Over the past 25 years, patients who have needed to have their hip joint replaced, either due to trauma or arthritic disease, typically have had their hip joint bone articular surfaces replaced with a metal hip stem, metal ball head (either stainless steel or chrome cobalt) and a plastic acetabular cup (metal/metal/plastic). While the basic device has remained essentially unchanged over that period, technological advancements in implant designs and materials, and improvements in surgical technique and instrumentation have made THA one of the most durable and successful procedures in medicine. Reproducible, high-quality, short-term and mid-term results are attained regularly, and total hip replacements commonly last 10 to 15 years and longer. The success of this procedure has allowed its expansion into a wider, and often younger and more active population. In spite of the improvements in THA, little change has occurred for the acetabular cup liner, which is usually made out of Ultra High Molecular Weight Polyethylene plastic (UHMWPe). Because it is plastic and inherently soft and somewhat pliable under load, the cup's articular surface must inevitability wear and produce debris. This biologic response is now thought to be a significant contributor to prosthetic component loosening, a primary failure mode of THR. UHMWPe also degrades with time in the body. As concerns about polyethylene wear and the associated untoward effects of the generated wear debris, and as THA continues to be used in younger and higher-demand patients with increasing life expectancies, interest in ceramic on ceramic total hip prosthesis has been renewed. An alumina ceramic-on-ceramic acetabular coupling has been employed as an alternative to metal/polyethylene couplings. This ceramic-on-ceramic coupling has many advantages, including the elimination of polyethylene from the device system, wear rates that are appreciably less than those experienced with metal/polyethylene couplings and reduced biologic reactivity. The potential benefits of an alumina ceramic/ceramic bearing are significant.
Interventions
DEVICE36 mm ceramic head on a ceramic acetabular liner
Total hip replacement with a 36 mm ceramic head on a ceramic liner
DEVICE28 mm ceramic head on a polyethylene acetabular liner
Total hip replacement with a 28 mm ceramic head on a polyethylene liner.
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia. * X-ray evaluation confirms the presence of NIDJD * Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants. * Individuals 20 to 75 years of age at the time of surgery * Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study. * Harris Hip Score of 70 or lower * Pain at least Moderate
Exclusion criteria
* Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated. * Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. * Acute femoral neck fracture. * Above knee amputation of the contralateral and/or ipsilateral leg. * Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements. * Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled. * Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months. * Patients with a known allergy to metal (e.g. jewelry). * Skeletally immature patients (tibial and femoral epiphyses are not closed). * Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.). * The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.). * Presence of known metastatic or neoplastic disease. * Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis). * Conditions that may interfere with the total hip arthroplasty's survival or outcome, (e.g., Paget's disease, Charcot's disease). * Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol. * Patient is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser. * Any systemic steroid therapy, excluding inhalers, within three months prior to surgery. * Patients carrying the diagnosis of inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatory arthritis and other arthritic processes of inflammatory or autoimmune etiology. * Patients requiring structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s). * Patients who refuse to provide consent to participate in the clinical investigation. * Surgical replacement requires the use of an acetabular liner and femoral head greater or smaller than a 36mm diameter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Harris Hip Score | At final follow-up visit, 24 months or later, up to 72 months | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Subscale Score: Function | At final follow-up visit, 24 months or later, up to 72 months | The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level. |
| Harris Hip Subscale Score: Activities | At final follow-up visit, 24 months or later, up to 72 months | The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities. |
| Harris Hip Subscale Score: Deformity | At final follow-up visit, 24 months or later, up to 72 months | The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity. |
| Harris Hip Subscale Score: Pain | At final follow-up visit, 24 months or later, up to 72 months | The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain. |
| Harris Hip Score Longitudinal Analysis | 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time. |
| Proportion of Composite Successes | At final follow-up visit, 24 months or later, up to 72 months | A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis. |
| Harris Hip Subscale Score: Range of Motion | At final follow-up visit, 24 months or later, up to 72 months | The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion. |
Countries
United States
Participant flow
Recruitment details
Patients were selected for recruitment into the study from the general diagnosis population defined as primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD). The investigation was conducted at 5 centers. The same inclusion and exclusion criteria applied to both investigational and control groups.
Pre-assignment details
1 subject was excluded from the study intraoperatively due to a ceramic liner fracture. Liner fracture was included in the Adverse Event data reported, but the subject was not included in the the number of participants because there are no follow-up data on this subject outside of operative details.
Participants by arm
| Arm | Count |
|---|---|
| 36 mm Ceramic-on-ceramic 36 mm ceramic head on ceramic acetabular liner 36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner | 168 |
| 28 mm Ceramic-on-polyethylene 28 mm ceramic-on-polyethylene historical control 28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner. | 74 |
| Total | 242 |
Baseline characteristics
| Characteristic | 36 mm Ceramic-on-ceramic | 28 mm Ceramic-on-polyethylene | Total |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 11 | 56.9 years STANDARD_DEVIATION 9.7 | 57.2 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 168 participants | 74 participants | 242 participants |
| Sex: Female, Male Female | 76 Participants | 27 Participants | 103 Participants |
| Sex: Female, Male Male | 92 Participants | 47 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 134 / 169 | 60 / 74 |
| serious Total, serious adverse events | 0 / 169 | 0 / 74 |
Outcome results
Primary
Total Harris Hip Score
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Total Harris Hip Score | 95.6 units on a scale | Standard Deviation 8.8 |
| 28 mm Ceramic-on-polyethylene | Total Harris Hip Score | 94.9 units on a scale | Standard Deviation 8.9 |
p-value: <0.001ANCOVA
Secondary
Harris Hip Score Longitudinal Analysis
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.
Time frame: 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively
Population: The population for this endpoint analysis is comprised of subjects who had Harris Hip scores at respective follow-up visits minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Harris Hip Score Longitudinal Analysis | 6 week Total Harris Hip Score | 52.6 units on a scale | Standard Deviation 10.9 |
| 36 mm Ceramic-on-ceramic | Harris Hip Score Longitudinal Analysis | 6 month Total Harris Hip Score | 93.1 units on a scale | Standard Deviation 10 |
| 36 mm Ceramic-on-ceramic | Harris Hip Score Longitudinal Analysis | 12 month Total Harris Hip Score | 95.5 units on a scale | Standard Deviation 6.5 |
| 36 mm Ceramic-on-ceramic | Harris Hip Score Longitudinal Analysis | 24 month Total Harris Hip Score | 95.7 units on a scale | Standard Deviation 8.2 |
| 36 mm Ceramic-on-ceramic | Harris Hip Score Longitudinal Analysis | 36 month Total Harris Hip Score | 96.6 units on a scale | Standard Deviation 6.8 |
| 36 mm Ceramic-on-ceramic | Harris Hip Score Longitudinal Analysis | 48 month Total Harris Hip Score | 94.6 units on a scale | Standard Deviation 10.1 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Score Longitudinal Analysis | 36 month Total Harris Hip Score | 97.0 units on a scale | Standard Deviation 4.6 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Score Longitudinal Analysis | 6 week Total Harris Hip Score | 52.0 units on a scale | Standard Deviation 9.5 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Score Longitudinal Analysis | 24 month Total Harris Hip Score | 93.7 units on a scale | Standard Deviation 10.2 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Score Longitudinal Analysis | 6 month Total Harris Hip Score | 93.4 units on a scale | Standard Deviation 9.7 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Score Longitudinal Analysis | 48 month Total Harris Hip Score | 93.5 units on a scale | Standard Deviation 11.1 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Score Longitudinal Analysis | 12 month Total Harris Hip Score | 95.2 units on a scale | Standard Deviation 7.6 |
Comparison: A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.p-value: 0.952Mixed Models Analysis
Secondary
Harris Hip Subscale Score: Activities
The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Harris Hip Subscale Score: Activities | 13.2 units on a scale | Standard Deviation 1.4 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Subscale Score: Activities | 13.0 units on a scale | Standard Deviation 1.7 |
Secondary
Harris Hip Subscale Score: Deformity
The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Harris Hip Subscale Score: Deformity | 4.0 units on a scale | Standard Deviation 0 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Subscale Score: Deformity | 4.0 units on a scale | Standard Deviation 0 |
Secondary
Harris Hip Subscale Score: Function
The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Harris Hip Subscale Score: Function | 32.1 units on a scale | Standard Deviation 2.5 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Subscale Score: Function | 31.6 units on a scale | Standard Deviation 4 |
Secondary
Harris Hip Subscale Score: Pain
The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Harris Hip Subscale Score: Pain | 41.4 units on a scale | Standard Deviation 6.3 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Subscale Score: Pain | 41.1 units on a scale | Standard Deviation 5.7 |
Secondary
Harris Hip Subscale Score: Range of Motion
The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 36 mm Ceramic-on-ceramic | Harris Hip Subscale Score: Range of Motion | 4.9 units on a scale | Standard Deviation 0.1 |
| 28 mm Ceramic-on-polyethylene | Harris Hip Subscale Score: Range of Motion | 4.9 units on a scale | Standard Deviation 0.2 |
Secondary
Proportion of Composite Successes
A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Population: Per Protocol subjects with radiographic endpoints, and including subjects who have been revised (these are composite endpoint failures).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 36 mm Ceramic-on-ceramic | Proportion of Composite Successes | 90.5 percentage of participants |
| 28 mm Ceramic-on-polyethylene | Proportion of Composite Successes | 90.1 percentage of participants |