1 Orthopaedics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU2 Orthopaedic Research Unit, Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense C, Denmark. email@example.com unknown4 Center Lillebaelt, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU5 Orthopaedics, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU6 Center Lillebaelt, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU
a randomized controlled trial protocol
BACKGROUND: Surgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization. METHODS/DESIGN: A prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a positive effect of treatment (>10 points on KOOS-ADL) will be reported. DISCUSSION: This is the first randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee. TRIAL REGISTRATION: ClinicalTrials NCT01891266.
Bmc Musculoskeletal Disorders, 2014, Vol 15
Aged; Analgesics; Animals; Arthroplasty, Replacement, Knee; Biopsy; Blood Loss, Surgical; Clinical Protocols; Denmark; Equipment Design; Follow-Up Studies; Humans; Medical Records; Mice; Microcomputers; Middle Aged; Osteoarthritis, Knee; Pain, Postoperative; Patient Satisfaction; Patient Selection; Postoperative Complications; Prospective Studies; Quadriceps Muscle; Randomized Controlled Trials as Topic; Range of Motion, Articular; Recovery of Function; Severity of Illness Index; Single-Blind Method; Tourniquets; Treatment Outcome