N/A
N=45
Blood Flow Restriction Following ACL Reconstruction
Anterior Cruciate Ligament Rupture
Bottom Line
View on ClinicalTrials.gov: NCT03758755 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: International Knee Documentation Committee (IKDC) Questionnaire Score — 47.40; 50.80; 61.83; 52.86 score on a scale — p=0.0219
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Flow Restriction Therapy (Device); ACL Reconstruction rehabilitation (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Inova Health Care Services
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Knee Documentation Committee (IKDC) Questionnaire Score |
47.40; 50.80; 61.83; 52.86 | 0.0219 sig |
| PRIMARY Visual Analog Score |
2.36; 3.18; 2.72; 3.16; 1.00; 1.51 | 0.008 sig |
| PRIMARY Quadriceps Tendon Strength |
58.88; 51.35; 63.68; 66.13; 75.73; 68.51 | 0.011 sig |
| PRIMARY Thigh Circumference |
99.23; 101.62; 97.02; 97.68; 94.55; 97.11 | 0.223 |
| PRIMARY Degrees of Knee Flexion |
51.54; 41.9; 76.4; 70.00; 102.02; 91.75 | 0.242 |
| PRIMARY Degrees of Knee Extension |
-6.88; -5.25; -3.60; -3.20; -0.32; -0.09 | 0.049 sig |
| SECONDARY Adverse Effects |
0; 0 | — |
Summary
The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.
Eligibility Criteria
Inclusion Criteria
- Age 13-35 years at the time of surgery
- Anterior Cruciate Ligament (ACL) reconstruction
- Using a physical therapy center with Blood Flow Restriction capabilities.
Exclusion Criteria
- Concomitant ligament reconstruction
- Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc)
- History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
- Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.)
- History of coagulation disorders or current use of anticoagulants
- Completion of physical therapy at a location not affiliated with the study
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03758755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.