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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03800225

Enrollment

Registered

2019-01-11

Start date

2019-01-03

Completion date

2019-09-04

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injury, Ligament; Laxity, Knee

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.

Interventions

PROCEDURERepair

Anterior ligament repair with internal brace.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Anterior cruciate ligament rupture

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Knee Laxity	12 Months	KT-1000 arthrometer

Secondary

Measure	Time frame	Description
Patient reported outcome scores	12 Months	Koos (Knee injury and Osteoarthritis Outcome Score)
Pain measurement	12 Months	NRS-pain score (Numeric rating scale) (10 worst pain - 0 No pain)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026