Last reviewed · How we verify
NCT04366336: BFRT-TKA
BFRT vs Standard PT After Total Knee Arthroplasty
NA trial testing Blood Flow Restriction Training in Total Knee Arthroplasty. Withdrawn.
29 December 2021
Quick facts
| Lead sponsor | Norton Healthcare |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 18 February 2021 |
| Primary completion | 29 December 2021 |
| Estimated completion | 29 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blood Flow Restriction Training
- Standard Physical Therapy
Conditions studied
- Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
Sponsor
Norton Healthcare — full company profile →
Who can join
Adults 50 to 70, any sex, with Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training. Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol. Primary Outcome Measures: Quadriceps Strength: dynamometry (hand held) Secondary Outcomes Measures: Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04366336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Blood Flow Restriction Training
Trials testing the same drug.
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- NCT07140796 — Effects of Hip Blood Flow Restriction and Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum · NA · not yet recruiting
- NCT06490692 — The Effect of Blood Flow Restriction Training on Tennis Elbow · NA · recruiting
- NCT06536777 — Effects of Ballistic Six Exercises With and Without Blood Flow Restriction in Cricket Players · NA · recruiting
- NCT06928181 — Effects of Passive Blood-Flow-Restriction on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty · NA · completed
Other recruiting trials for Total Knee Arthroplasty
Currently open trials in the same condition.
- NCT07524387 — Femoral Triangle Block vs Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty · NA · recruiting
- NCT07511842 — REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes · NA · recruiting
- NCT07324954 — Methylene Blue in Total Knee Arthroplasty (TKA) · Phase 1 · recruiting
- NCT07336160 — ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty · NA · recruiting
- NCT07371390 — Minimal Sedation During Knee Replacement Surgery · NA · recruiting
Other Norton Healthcare trials
Trials by the same sponsor.
- NCT04900285 — Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring · NA · unknown
- NCT04364867 — Exparel for Total Shoulder Arthroplasty · Phase 4 · completed
- NCT02966184 — Comparison of Albuterol for Status Asthmaticus · Phase 4 · terminated
- NCT02819479 — Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04366336 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Norton Healthcare
- Last refreshed: 7 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04366336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing