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NCT03800225 Clinical Trial

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

Anterior Cruciate Ligament Injury Clinical Trial

Official title:
Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study Comparing Internal Brace Repair and a Patella Tendon Autograft Reconstruction.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03800225
Other study ID # Danish EC - 1-10-72-223-18.
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 3, 2019
Est. completion date September 4, 2019

Study information
Verified date September 2019
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date September 4, 2019
Est. primary completion date September 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Anterior cruciate ligament rupture

Exclusion Criteria:

- Current malignant disease

- Rheumatoid arthritis

- Other knee ligament instability

- Obesity BMI >30

- Morbus Bechterew

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Repair
Anterior ligament repair with internal brace.

Locations
Country Name City State
Denmark Division of Sports Trauma, Palle Juul-Jensens Boulevard 99 Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Knee Laxity KT-1000 arthrometer 12 Months
Secondary Patient reported outcome scores Koos (Knee injury and Osteoarthritis Outcome Score) 12 Months
Secondary Patient reported outcome scores IKDC (International Knee Documentation Committee) 12 Months
Secondary Pain measurement NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain) 12 Months
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