Trials / Terminated
TerminatedNCT04941729
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the OR3O™ Dual Mobility System Versus Conventional Single Bearing Design Total Hip System in Primary Total Hip Arthroplasty (THA) Procedures.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3O™ Dual Mobility System in China as well as to support and maintain product registration in global markets. Primary Objective: Assess safety and efficacy of the OR3O™ Dual Mobility System in Primary THA at 1 year postoperative. Secondary Objective(s): Assess safety and efficacy of the OR3O™ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery. Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation. 4 study sites in China.
Conditions
- Degenerative Hip Joint Disease
- Rheumatoid Arthritis (RA)
- Femoral Neck Fractures
- Avascular Necrosis of Femoral Head
- Osteoarthritis (OA)
- Hip Dislocation
- Hip Fractures
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OR3O™ - Dual Mobility System | OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert). |
| DEVICE | Conventional | A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith \& Nephew Oxinium (Ox) femoral head. |
Timeline
- Start date
- 2022-06-24
- Primary completion
- 2023-11-03
- Completion
- 2023-11-03
- First posted
- 2021-06-28
- Last updated
- 2025-05-21
- Results posted
- 2025-05-21
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04941729. Inclusion in this directory is not an endorsement.