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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Replacement
ACL Rupture

Treatments

Other: RX
Other: Questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT01138696
2009/670

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

49 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

80 participants in 2 patient groups

Stryker Dacron synthetic graft
Treatment:
Other: RX
Other: Questionnaires
Trevira synthetic graft
Treatment:
Other: RX
Other: Questionnaires

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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