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

NCT03342222 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-04-30

No results posted yet for this study

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

  • PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Interventions

DEVICE

Interference Screws

tibial fixation for ACL reconstruction

Sponsors & Collaborators

  • Rejoin Hangzhou Martins Medical Equipment Co., Ltd.

    collaborator UNKNOWN

  • Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2019-11-20
Completion
2019-11-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03342222 on ClinicalTrials.gov