The design of a randomised controlled trial to evaluate the (cost-) effectiveness of the posterolateral versus the direct anterior approach for THA (POLADA - trial)

• Published in: BMC musculoskeletal disorders 2016-11, Vol.17 (1), p.476, Article 476
• Main Authors: Rykov, K, Reininga, I H F, Knobben, B A S, Sietsma, M S, Ten Have, B L E F
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Arthritis; Arthroplasty, Replacement, Hip - economics; Arthroplasty, Replacement, Hip - instrumentation; Arthroplasty, Replacement, Hip - methods; Bone Cements - therapeutic use; Consent; Cost-Benefit Analysis; Female; Hip Joint; Hip Prosthesis; Humans; Joint replacement surgery; Knee; Learning curves; Male; Middle Aged; Minimally Invasive Surgical Procedures - economics; Minimally Invasive Surgical Procedures - instrumentation; Minimally Invasive Surgical Procedures - methods; Musculoskeletal diseases; Netherlands; Orthopedics; Osteoarthritis; Osteoarthritis, Hip - surgery; Patients; Postoperative Period; Quality of Life; Recovery of Function; Research Design; Rotator cuff; Study Protocol; Surveys and Questionnaires; Systematic review; Young Adult
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-016-1322-2

Total hip arthroplasty (THA) is one of the most successful orthopaedic procedures. Because of the increasing number of THAs, a growing demand for faster recovery and a greater emphasis on cost-effectiveness, minimally invasive THAs have been introduced in the last decades. The direct anterior approach is a minimally invasive, tissue-sparing approach in which intermuscular planes are used. Theoretically, this approach should result in a faster recovery of physical functioning and higher health-related quality of life. A randomised controlled trial will be performed. Patients will be randomly allocated to undergo THA by means of the anterior or posterolateral approach. Both the intervention and control group will consist of two subgroups: 1) patients with a good bone stock who will receive an uncemented femoral stem, and 2) patients with a poor bone stock who will receive a cemented femoral stem. Patients between 18 and 90 years with primary or secondary osteoarthritis will be included. Physical functioning and health-related quality of life will be assessed by means of questionnaires. Additionally, performance based tests will be performed to objectively assess the physical functioning. Cost-effectiveness will be assessed by obtaining data on medical costs in and outside the hospital and other nonmedical costs. Measurements will take place preoperatively, two and six weeks, three months and one year postoperatively. There is some evidence that the anterior approach results in reduced tissue damage and faster recovery in the direct postoperative period, compared to the posterolateral approach. However, there is still a lack of well-designed studies that have confirmed the better outcomes and cost-effectiveness of the anterior approach. Therefore, the purpose of this study is to assess the physical functioning, health related quality of life and the cost-effectiveness of the anterior approach, compared to the conventional posterolateral approach. Netherlands Trial Registry, number 5343 (registration date April 12, 2015).