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

NCT ID: NCT03342222

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Keywords

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PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEEK Interference Screws

PEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd.

Group Type EXPERIMENTAL

Interference Screws

Intervention Type DEVICE

tibial fixation for ACL reconstruction

Biosure PK interference screw

Biosure PK interference screw from Smith \& Nephew plc.

Group Type ACTIVE_COMPARATOR

Interference Screws

Intervention Type DEVICE

tibial fixation for ACL reconstruction

Interventions

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Interference Screws

tibial fixation for ACL reconstruction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Voluntarily sign the informed consent form; Between the ages of 18 and 75; Positive ADT and positive Lachman test. Unilateral anterior cruciate ligament is confirmed by MRI (without posterior cruciate ligament injury or reconstruction); Tolerated for anterior cruciate ligament reconstruction surgery; Normal contralateral knee

Exclusion Criteria

1. Do not meet the diagnostic criteria of anterior cruciate ligament injury;
2. With posterior cruciate ligament fracture at the same time;
3. X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury);
4. Knee flexion less than 90 degree;
5. Abnormal body anatomy;
6. Pregnant, breast-feeding or subjects who plan to become pregnant;
7. Serious osteoporosis, malignant tumors;
8. Allergic to implant materials;
9. Patients with severe malnutrition who can not tolerate surgery;
10. Severe coagulopathy, such as hemophilia;
11. Immunodeficiency diseases, including those requiring long-term use of immunosuppressive agents;
12. The injured knee has a wide range of skin diseases;
13. Serious obese patients (BMI\> 35);
14. Patients with severe mental illness can not cooperate with postoperative rehabilitation and patients with severe cardiopulmonary disease can not tolerate surgery;
15. Ipsilateral lower extremity received surgery within the past year;
16. Has participated in any other clinical trial in the past three months;
17. Can not comply with the requirements of the study;
18. Those who the investigator thinks they are inappropriate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rejoin Hangzhou Martins Medical Equipment Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role lead

Responsible Party

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Hongbin Lu

Porfessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xi He, MD

Role: CONTACT

Phone: 86-073189753059

Email: [email protected]

Facility Contacts

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Lu Hongbin, M.D. & Ph.D.

Role: primary

Other Identifiers

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JMST-01

Identifier Type: -

Identifier Source: org_study_id