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

NCT01138696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-12-15

No results posted yet for this study

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.

Conditions

  • ACL Rupture
  • Replacement

Interventions

OTHER

Questionnaires

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

OTHER

RX

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

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • René Verdonk, MD, PhD · University Hospital, Ghent

Eligibility

Min Age
49 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138696 on ClinicalTrials.gov