Trials / Unknown
UnknownNCT03342222
The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Central South University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions. 120 Subjects with ACL injury were randomly assigned to two groups for ACL reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference screw (Smith \& Nephew plc). The subjects will be followed by 12 months after surgery for evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Interference Screws | tibial fixation for ACL reconstruction |
Timeline
- Start date
- 2017-11-20
- Primary completion
- 2019-11-20
- Completion
- 2019-11-20
- First posted
- 2017-11-14
- Last updated
- 2018-04-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03342222. Inclusion in this directory is not an endorsement.