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NCT03342222

The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction

Status unknown Phase 3 Last updated 30 April 2018
What this trial tests

Phase 3 trial testing Interference Screws in PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction in 120 participants. Status unknown.

Timeline
20 November 2017
Primary endpoint
20 November 2019
20 November 2019

Quick facts

Lead sponsorCentral South University
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment120
Start date20 November 2017
Primary completion20 November 2019
Estimated completion20 November 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

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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Other Central South University trials

Trials by the same sponsor.

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Data sources for this page

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