N/A
Completed N=265
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
Non-inflammatory Degenerative Joint Disease
Source: ClinicalTrials.gov NCT00561600 ↗
Enrolled (actual)
265
Serious AEs
—
Results posted
May 2014
Primary outcomePrimary: Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes — 82; 92 participants — p=0.872
Summary
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes |
82; 92 | 0.872 |
| SECONDARY T-Test of Harris Hip Total Score Means at 24 Months |
94.8; 96.4 | 0.167 |
| SECONDARY Harris Hip Pain Sub Score at 24 Months |
41.5; 42.7 | — |
| SECONDARY Harris Hip Function Score at 24 Months |
31.4; 31.6 | — |
| SECONDARY Analysis of Metal Ion Release - Serum Cobalt |
3.16; 1.83 | 0.048 sig |
| SECONDARY Analysis of Metal Ion Release - Serum Chromium |
2.04; 1.66 | 0.782 |
| SECONDARY Analysis of Metal Ion Release - Erythrocyte Cobalt |
1.90; 1.18 | 0.061 |
| SECONDARY Analysis of Metal Ion Release - Erythrocyte Chromium |
0.62; 0.62 | 0.957 |
Eligibility Criteria
Inclusion Criteria
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject is between the ages of 20-75 years, inclusive.
- Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
- Subject has sufficient bone stock for the hip replacement device.
- Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.
Exclusion Criteria
- Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
- Subject with a known allergy to metal (e.g. jewelry).
- Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
- Subject has active or recent joint sepsis.
- Subject with marked atrophy or deformity in the upper femur.
- Subject with a neuromuscular disease where the loss of musculature would affect functional outcome.
- Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis).
- Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery.
- Subject with known, active metastatic or neoplastic disease.
- Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser.
- Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.
Data sourced from ClinicalTrials.gov (NCT00561600). 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. Informational only — not medical advice.