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

Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138696
• Other study ID #: 2009/670
• Status: Completed
• Start date: February 2010
• Est. completion date: July 2015

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 49 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Rupture
• Replacement
• Rupture

Intervention

Other:
• Questionnaires
KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),
• RX
X-rays and clinical investigation of the knee 20 years after surgery

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis	Aalst
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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

External Links

•   website University Hospital Ghent