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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01138696
First received: April 22, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
ACL Rupture
Replacement
Other: Questionnaires
Other: RX

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for ACL Repair

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury [ Time Frame: 20 years after surgery ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament. [ Time Frame: 20 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stryker Dacron synthetic graft Other: Questionnaires
KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),
Other: RX
X-rays and clinical investigation of the knee 20 years after surgery
Trevira synthetic graft Other: Questionnaires
KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),
Other: RX
X-rays and clinical investigation of the knee 20 years after surgery

  Eligibility

Ages Eligible for Study:   49 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138696

Contacts
Contact: René Verdonk, MD, PhD rene.verdonk@ugent.be

Locations
Belgium
Algemeen Stedelijk Ziekenhuis Recruiting
Aalst, Belgium
Principal Investigator: F. Steenbrugge, MD         
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: René Verdonk, MD, PhD         
Principal Investigator: Fredrik Almqvist, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: René Verdonk, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138696     History of Changes
Other Study ID Numbers: 2009/670
Study First Received: April 22, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
ACL

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 19, 2014