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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138696
First Posted: June 7, 2010
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  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 ]
    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 ]

Estimated Enrollment: 80
Study Start Date: February 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01138696     History of Changes
Other Study ID Numbers: 2009/670
First Submitted: April 22, 2010
First Posted: June 7, 2010
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
ACL

Additional relevant MeSH terms:
Rupture
Wounds and Injuries