MRI-BASED GRAFT MATURITY AFTER BLOOD FLOW RESTRICTION TRAINING IN BONE-PATELLAR TENDON-BONE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A RANDOMIZED CONTROLLED STUDY

Phase 3

• Conditions: knee injury; 10043237; ruptured cruciate ligament

• Registration Number: NL-OMON56498
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

Patients who will undergo primary BPTB reconstruction at Zuyderland Medical
Center and rehabilitation at Knie-Heup centrum Plus.

Exclusion Criteria

The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe
hypertension, contra-indication for accelerated rehabilitation,
contra-indication for MRI scan or not willing/able to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The effect of LL-BFRT on MRI-based graft maturity three months after BPTB ACL<br /><br>reconstruction compared to HLRT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of LL-BFRT on donor-site morbidity, range of motion, knee stability,<br /><br>PROMs, muscle strength, safe return to pre-injury level of sport and patient<br /><br>satisfaction compared to HLRT. Furthermore, feasibility and safety of<br /><br>rehabilitation (LL-BFRT or HLRT) will be assessed.</p><br>