Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for Anterior Cruciate Ligament (ACL) Repair
1 other identifier
observational
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 15, 2022
December 1, 2022
5.4 years
April 22, 2010
December 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament.
20 years after surgery
Study Arms (2)
Stryker Dacron synthetic graft
Trevira synthetic graft
Interventions
KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),
X-rays and clinical investigation of the knee 20 years after surgery
Eligibility Criteria
Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
You may qualify if:
- Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
- Max age: 75
- Min age: 49
- Minimum follow up: 22 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium
University Hospital Ghent
Ghent, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
René Verdonk, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
June 7, 2010
Study Start
February 1, 2010
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
December 15, 2022
Record last verified: 2022-12