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

Study Overview
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Brief Summary
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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.

Official Title
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Long Term Follow-up of the Stryker Dacron and Trevira Ligament for ACL Repair

Conditions
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ACL Rupture, Replacement

Intervention / Treatment
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* Other: Questionnaires
* Other: RX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stryker Dacron synthetic graft<br> | Other: Questionnaires<br>* KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),<br>Other: RX<br>* X-rays and clinical investigation of the knee 20 years after surgery<br>|
| Trevira synthetic graft<br> | Other: Questionnaires<br>* KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),<br>Other: RX<br>* X-rays and clinical investigation of the knee 20 years after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury | 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 | 20 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament. |  | 20 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL