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N/A N=243 Treatment

36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement

Non-inflammatory Degenerative Joint Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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