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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01138696

Enrollment

Registered

2010-06-07

Start date

2010-02-28

Completion date

2015-07-31

Last updated

2022-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Rupture, Replacement

Keywords

ACL

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.

Interventions

OTHERQuestionnaires

KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),

OTHERRX

X-rays and clinical investigation of the knee 20 years after surgery

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

49 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026