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

NCT ID: NCT01138696

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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ACL Rupture Replacement

Keywords

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ACL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stryker Dacron synthetic graft

Questionnaires

Intervention Type OTHER

KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),

RX

Intervention Type OTHER

X-rays and clinical investigation of the knee 20 years after surgery

Trevira synthetic graft

Questionnaires

Intervention Type OTHER

KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),

RX

Intervention Type OTHER

X-rays and clinical investigation of the knee 20 years after surgery

Interventions

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Questionnaires

KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),

Intervention Type OTHER

RX

X-rays and clinical investigation of the knee 20 years after surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

49 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René Verdonk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Algemeen Stedelijk Ziekenhuis

Aalst, , Belgium

Site Status

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website University Hospital Ghent

Other Identifiers

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2009/670

Identifier Type: -

Identifier Source: org_study_id