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NCT03342222
The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Phase 3 trial testing Interference Screws in PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction in 120 participants. Status unknown.
20 November 2019
Quick facts
| Lead sponsor | Central South University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 20 November 2017 |
| Primary completion | 20 November 2019 |
| Estimated completion | 20 November 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Interference Screws
Conditions studied
- PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction — all drugs for PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction →
Sponsor
Central South University
Who can join
Adults 18 to 75, any sex, with PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03342222 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central South University
- Last refreshed: 30 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03342222.
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