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

April 27, 2018 updated by: Hongbin Lu, Central South University

Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEK Interference Screws
PEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd.
Device: Interference Screws
tibial fixation for ACL reconstruction
Active Comparator: Biosure PK interference screw
Biosure PK interference screw from Smith & Nephew plc.
Device: Interference Screws
tibial fixation for ACL reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patients with Lysholm score more than 70 score
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Lysholm score
Time Frame: 1month; 3month; 6 month; 12 month
1month; 3month; 6 month; 12 month
IKDC
Time Frame: 1month; 3month; 6 month; 12 month
1month; 3month; 6 month; 12 month
Anterior drawer test
Time Frame: 1month; 3month; 6 month; 12 month
1month; 3month; 6 month; 12 month
Lachman test
Time Frame: 1month; 3month; 6 month; 12 month
1month; 3month; 6 month; 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Collaborators

Rejoin Hangzhou Martins Medical Equipment Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Anticipated)

November 20, 2019

Study Completion (Anticipated)

November 20, 2019

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JMST-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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