N/A
N=243
36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement
Non-inflammatory Degenerative Joint Disease
Bottom Line
View on ClinicalTrials.gov: NCT00953719 ↗Enrolled (actual)
243
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Total Harris Hip Score — 95.6; 94.9 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 36 mm ceramic head on a ceramic acetabular liner (Device); 28 mm ceramic head on a polyethylene acetabular liner (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- DePuy Orthopaedics
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Harris Hip Score |
95.6; 94.9 | <0.001 sig |
| SECONDARY Harris Hip Subscale Score: Pain |
41.4; 41.1 | — |
| SECONDARY Harris Hip Subscale Score: Function |
32.1; 31.6 | — |
| SECONDARY Harris Hip Subscale Score: Activities |
13.2; 13.0 | — |
| SECONDARY Harris Hip Subscale Score: Deformity |
4.0; 4.0 | — |
| SECONDARY Harris Hip Subscale Score: Range of Motion |
4.9; 4.9 | — |
| SECONDARY Harris Hip Score Longitudinal Analysis |
52.6; 52.0; 93.1; 93.4; 95.5; 95.2 | 0.952 |
| SECONDARY Proportion of Composite Successes |
90.5; 90.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00953719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.