The Safety and Effectiveness of PEEK Interference Screws... | NCT03342222

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

NCT03342222

Sponsor

Central South University

Status

Unknown status

Last Update Posted

Apr 30, 2018Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction

Interventions

Interference Screws

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2017Actual

Primary Completion Date

Nov 20, 2019Estimated

Completion Date

Nov 20, 2019Estimated

First Submitted Date

Nov 9, 2017

First Submission Date that Met QC Criteria

Nov 10, 2017

First Posted Date

Nov 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2018

Last Update Posted Date

Apr 30, 2018Actual

Name	Class
Rejoin Hangzhou Martins Medical Equipment Co., Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEEK Interference Screws	Experimental	PEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd.	Device: Interference Screws
Biosure PK interference screw	Active Comparator	Biosure PK interference screw from Smith & Nephew plc.	Device: Interference Screws

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interference Screws	Device	tibial fixation for ACL reconstruction	Biosure PK interference screw PEEK Interference Screws

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

Measure	Description	Time Frame
Lysholm score		1month; 3month; 6 month; 12 month
IKDC		1month; 3month; 6 month; 12 month
Anterior drawer test

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided