Back to resultsTreatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.
Primary Purpose
Ligament; Laxity, Knee, Anterior Cruciate Ligament Injury
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Repair
Sponsored by
About this trial
This is an interventional health services research trial for Ligament; Laxity, Knee
Eligibility Criteria
Inclusion Criteria:
- Anterior cruciate ligament rupture
Exclusion Criteria:
- Current malignant disease
- Rheumatoid arthritis
- Other knee ligament instability
- Obesity BMI >30
- Morbus Bechterew
Sites / Locations
- Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Repair
Patella tendon graft
Arm Description
Anterior cruciate ligament repair with internal brace after anterior ligament rupture.
The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.
Outcomes
Primary Outcome Measures
Knee Laxity
KT-1000 arthrometer
Secondary Outcome Measures
Patient reported outcome scores
Koos (Knee injury and Osteoarthritis Outcome Score)
Patient reported outcome scores
IKDC (International Knee Documentation Committee)
Pain measurement
NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)
Full Information
NCT ID
NCT03800225
First Posted
January 9, 2019
Last Updated
September 30, 2019
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03800225
Brief Title
Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
A new scientific study shows that surgery with internal brace is worse than convensional surgery tecnic. This new knowledge stops this trial.
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
September 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament; Laxity, Knee, Anterior Cruciate Ligament Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Repair
Arm Type
Experimental
Arm Description
Anterior cruciate ligament repair with internal brace after anterior ligament rupture.
Arm Title
Patella tendon graft
Arm Type
Active Comparator
Arm Description
The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture.
Intervention Type
Procedure
Intervention Name(s)
Repair
Intervention Description
Anterior ligament repair with internal brace.
Primary Outcome Measure Information:
Title
Knee Laxity
Description
KT-1000 arthrometer
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Patient reported outcome scores
Description
Koos (Knee injury and Osteoarthritis Outcome Score)
Time Frame
12 Months
Title
Patient reported outcome scores
Description
IKDC (International Knee Documentation Committee)
Time Frame
12 Months
Title
Pain measurement
Description
NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anterior cruciate ligament rupture
Exclusion Criteria:
Current malignant disease
Rheumatoid arthritis
Other knee ligament instability
Obesity BMI >30
Morbus Bechterew
Facility Information:
Facility Name
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Anterior Ligament Rupture With Internal Brace Repair - A Prospective Randomised Controlled Study.
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