Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol

Autor:	Lasse Enkebølle Rasmussen, Andreas Kappel, Anders Odgaard, Frank Madsen, Jacob Fyhring Mortensen, Henrik Morville Schrøder, Svend Erik Østgaard
Jazyk:	angličtina
Rok vydání:	2019
Předmět:	Male lcsh:Diseases of the musculoskeletal system Sports medicine medicine.medical_treatment Knee replacement Femur/diagnostic imaging Osteoarthritis Prosthesis law.invention Study Protocol 0302 clinical medicine Randomized controlled trial law Orthopedics and Sports Medicine Femur Prospective Studies Prospective cohort study Arthroplasty Replacement Knee Child 030222 orthopedics Rehabilitation Tibia/diagnostic imaging Osteoarthritis Knee Osteoarthritis Knee/diagnostic imaging Child Preschool Anteromedial osteoarthritis Female Medial Unicondylar knee arthroplasty musculoskeletal diseases medicine.medical_specialty Adolescent 03 medical and health sciences Young Adult Rheumatology Double-Blind Method medicine Humans 030203 arthritis & rheumatology Tibia business.industry Infant Newborn Infant OKS medicine.disease Total knee arthroplasty Orthopedic surgery Physical therapy lcsh:RC925-935 business Arthroplasty Replacement Knee/methods Follow-Up Studies
Zdroj:	BMC Musculoskeletal Disorders, Vol 20, Iss 1, Pp 1-8 (2019) Mortensen, J F, Rasmussen, L E, Østgaard, S E, Kappel, A, Madsen, F, Schrøder, H M & Odgaard, A 2019, ' Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol ', BMC Musculoskeletal Disorders, vol. 20, 119, pp. 1-8 . https://doi.org/10.1186/s12891-019-2508-1 Mortensen, J F, Rasmussen, L E, Østgaard, S E, Kappel, A, Madsen, F, Schrøder, H M & Odgaard, A 2019, ' Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis : the study-protocol ', BMC Musculoskeletal Disorders, vol. 20, 119 . https://doi.org/10.1186/s12891-019-2508-1 BMC Musculoskeletal Disorders Mortensen, J F, Rasmussen, L E, Østgaard, S E, Kappel, A, Madsen, F, Schrøder, H M & Odgaard, A 2019, ' Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis : The study-protocol ', BMC Musculoskeletal Disorders, vol. 20, 119 . https://doi.org/10.1186/s12891-019-2508-1 Mortensen, J F, Rasmussen, L E, Østgaard, S E, Kappel, A, Madsen, F, Schrøder, H M & Odgaard, A 2019, ' Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. the study-protocol ', BMC Musculoskeletal Disorders, vol. 20, no. 1, 119, pp. 119 . https://doi.org/10.1186/s12891-019-2508-1
ISSN:	1471-2474
DOI:	10.1186/s12891-019-2508-1
Popis:	In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic. A double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years. Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded. OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT. ClinicalTrials.gov ID: NCT03396640 . Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.
Databáze:	OpenAIRE
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