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

Not Applicable

Terminated

• Conditions: Ligament; Laxity, Knee; Anterior Cruciate Ligament Injury
• Interventions: Procedure: Repair

• Registration Number: NCT03800225
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Status Verified: 2019-09
• Primary Completion: 2019-09-04
• Study Completion: 2019-09-04
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Anterior cruciate ligament rupture

Exclusion Criteria

• Current malignant disease
• Rheumatoid arthritis
• Other knee ligament instability
• Obesity BMI >30
• Morbus Bechterew

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repair	Repair	Anterior cruciate ligament repair with internal brace after anterior ligament rupture.
Patella tendon graft	Repair	The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.

Primary Outcome Measures

Name	Time	Method
Knee Laxity	12 Months	KT-1000 arthrometer

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome scores	12 Months	IKDC (International Knee Documentation Committee)
Pain measurement	12 Months	NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)

Trial Locations

Locations (1)

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99; 🇩🇰 Aarhus N, Denmark