Trial results for the OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study, investigating the OXINIUM◊ DH Hip System in hip osteoarthritis, were posted on 2026-03-19. The study reported that 55 participants in the OXINIUM DH Hip System group achieved overall success at 730 days post-operative.
Background
Osteoarthritis is a degenerative joint disease that commonly affects the hip, leading to pain, stiffness, and reduced mobility. Total hip arthroplasty (THA) is a standard and effective treatment for advanced hip osteoarthritis, involving the surgical replacement of the hip joint with prosthetic components. The long-term performance and safety of these implants are critical for patient outcomes, making post-implantation monitoring studies important for evaluating new and existing systems.
Trial design
This pivotal study enrolled 413 participants with Hip Osteoarthritis. The primary purpose of the study was to monitor the safety of participants implanted with the OXINIUM◊ DH Hip System for up to 10 years post-implantation. The trial compared outcomes for the OXINIUM◊ DH Hip System against the BIOLOX◊ system.
Key results
Key measurements collected at 730 days post-operative for participants with a unilateral hip implant include:
- Overall Success at 730 Days Post-operative:
- OXINIUM DH Hip System: 55 Participants
- BIOLOX◊: 47 Participants
- Number of Unilateral Hip Implant Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points:
- OXINIUM DH Hip System: 144 Participants
- BIOLOX◊: 136 Participants
- Radiographic Success at 730 Days Postoperative - Radiolucencies:
- OXINIUM DH Hip System: 150 Participants
- BIOLOX◊: 136 Participants
- Radiographic Success at 730 Days Postoperative - Femoral or Acetabular Subsidence:
- OXINIUM DH Hip System: 154 Participants
- BIOLOX◊: 140 Participants
- Radiographic Success at 730 Days Postoperative - Acetabular Cup Inclination:
- OXINIUM DH Hip System: 84 Participants
- BIOLOX◊: 88 Participants
- Number of Unilateral Hip Implant Participants With Absence of Revision at 730 Days Postoperative:
- OXINIUM DH Hip System: 163 Participants
- BIOLOX◊: 148 Participants
What this means
The posted results indicate generally favorable outcomes for the OXINIUM◊ DH Hip System at two years post-implantation when compared to the BIOLOX◊ system. The OXINIUM DH Hip System demonstrated a higher count of participants achieving overall success (55 vs. 47), a modified Harris Hip Score of 80 points or greater (144 vs. 136), and absence of revision (163 vs. 148). Radiographic success metrics, including absence of radiolucencies (150 vs. 136) and femoral or acetabular subsidence (154 vs. 140), also showed higher participant counts for the OXINIUM DH Hip System. Acetabular cup inclination, however, was slightly higher for the BIOLOX◊ group (88 vs. 84). These findings contribute to the understanding of the short-to-medium term performance of these hip arthroplasty systems in patients with hip osteoarthritis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02353377, titled "OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study", were posted on 2026-03-19 on clinicaltrials.gov.
