Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.

NCT ID: NCT03800225

Last Updated: 2019-10-02

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

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2019-09-04

Brief Summary

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The purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.

Detailed Description

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Conditions

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Ligament; Laxity, Knee Anterior Cruciate Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Repair

Anterior cruciate ligament repair with internal brace after anterior ligament rupture.

Group Type EXPERIMENTAL

Repair

Intervention Type PROCEDURE

Anterior ligament repair with internal brace.

Patella tendon graft

The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.

Group Type ACTIVE_COMPARATOR

Repair

Intervention Type PROCEDURE

Anterior ligament repair with internal brace.

Interventions

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Repair

Anterior ligament repair with internal brace.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Anterior cruciate ligament rupture

Exclusion Criteria

* Current malignant disease
* Rheumatoid arthritis
* Other knee ligament instability
* Obesity BMI \>30
* Morbus Bechterew
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Lind

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Danish EC - 1-10-72-223-18.

Identifier Type: -

Identifier Source: org_study_id

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