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

• Sponsor: Central South University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03342222
• Collaborator: Rejoin Hangzhou Martins Medical Equipment Co., Ltd. (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction	Device: Interference Screws	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
• Actual Study Start Date: Nov 20, 2017
• Anticipated Primary Completion Date: Nov 20, 2019
• Anticipated Study Completion Date: Nov 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. percentage of patients with Lysholm score more than 70 score [12 month]

Secondary Outcome Measures

1. Lysholm score [1month; 3month; 6 month; 12 month]

2. IKDC [1month; 3month; 6 month; 12 month]

3. Anterior drawer test [1month; 3month; 6 month; 12 month]

4. Lachman test [1month; 3month; 6 month; 12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiangya Hospital, Central South University	Changsha	Hunan	China	410008

Sponsors and Collaborators

• Central South University
• Rejoin Hangzhou Martins Medical Equipment Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongbin Lu, Porfessor, Central South University
• ClinicalTrials.gov Identifier: NCT03342222
• Other Study ID Numbers: JMST-01
• First Posted: Nov 14, 2017
• Last Update Posted: Apr 30, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hongbin Lu, Porfessor, Central South University: PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Study Results

No Results Posted as of Apr 30, 2018