Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for Anterior Cruciate Ligament (ACL) Repair

Completed

• Conditions: Replacement; ACL Rupture
• Interventions: Other: Questionnaires; Other: RX

• Registration Number: NCT01138696
• Lead Sponsor: University Hospital, Ghent

Brief Summary

About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. The situation of another group of patients on the other hand evolved favourably without complications. The study to focuses on this group of patients and attempts to determine how the replacement without problems ab initio, evolved in the time.

It concerns a group of 57 patients who received an implantation in the UZ Ghent between November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by means of standardized questionnaires and a clinical examination. The radiological result will be determined by the degree of integrity of the ligament that was implanted at the time. In this way the study could give an idea about the degree in which the technical success of the intervention correlates with the clinical success 20 years later.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
• Max age: 75
• Min age: 49
• Minimum follow up: 22 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stryker Dacron synthetic graft	RX	-
Trevira synthetic graft	RX	-
Stryker Dacron synthetic graft	Questionnaires	-
Trevira synthetic graft	Questionnaires	-

Primary Outcome Measures

Name	Time	Method
to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury	20 years after surgery	Pain is measured by the VAS-score. For the evaluation of safety and tolerability the patients fill in the Tegner, Lysholm, IKDC, KOOS and SF-36 questionnaires

Secondary Outcome Measures

Name	Time	Method
A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament.	20 years after surgery

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium