Comparing rehabilitation methods after knee surgery
Comparison of Methods in Post Operative Knee Arthroscopy Rehabilitation
This study is testing if using a special blood flow restriction therapy during rehab can help people recover better and faster after knee surgery for an ACL injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Centennial, Colorado) |
| Trial ID | NCT05735236 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of blood flow restriction (BFR) therapy in the rehabilitation process following knee arthroscopy for ACL reconstruction. Participants will be randomly assigned to either a treatment group using a BFR cuff or a control group without it, while both groups follow a standard physical therapy protocol for 12 weeks. The study aims to measure improvements in strength and functional recovery over a two-year period, using various patient-reported outcome measures and clinical assessments. The hypothesis is that BFR therapy will enhance recovery compared to standard rehabilitation alone.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair.
Not a fit: Patients with contraindications for BFR therapy or those undergoing bilateral knee surgeries within 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved strength for patients recovering from ACL surgery.
How similar studies have performed: Other studies have shown promising results with BFR therapy in rehabilitation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients undergoing primary knee arthroscopy for ACL reconstruction without meniscus repair
* Completing initial 12 weeks of physical therapy at the Steadman Hawkins Clinic in Denver
* Patients with access to smartphone device
Exclusion Criteria:
* Bilateral knee surgeries to be performed within 12 weeks of each other
* Patients received meniscus repairs, chondral lesion repair/transplants,
* Prior surgery on the same knee
* Anyone who meets the following contraindications for BFR therapy:
* Deep Vein Thrombosis (DVT)
* Pulmonary Embolism
* Hemorrhagic/Thrombolytic Stroke
* Clotting Disorders
* Hemophilia or taking blood thinners
* Pregnant or up to 6 months post-partum
* Untreated Hypertension
* Untreated Hypotension
* Rhabdomyolysis or recent traumatic injury
2\. Exclusion criteria will be evaluated via the medical record as well as by the expert opinion of the physician.
3\. If at any point in the study a subject develops one of the above contraindications, they will be removed from the study.
4\. If a subject becomes pregnant while participating in the intervention portion of the study, they will be removed.
Where this trial is running
Centennial, Colorado
- UCHealth Steadman Hawkins Clinic — Centennial, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: James Genuario, MD — University of Colorado, Denver
- Study coordinator: Lauren Heylmun, BS
- Email: lauren.heylmun@cuanschutz.edu
- Phone: 720-516-9823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.