Functional outcome of total knee replacement : a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants

Autor: Teemu Moilanen, Antti Eskelinen, Heini Huhtala, Jarmo Kangas, Ville M. Mattila, Tero Irmola, Mika Niemeläinen
Přispěvatelé: Lääketieteen ja terveysteknologian tiedekunta - Faculty of Medicine and Health Technology, Yhteiskuntatieteiden tiedekunta - Faculty of Social Sciences, Tampere University
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Male
lcsh:Diseases of the musculoskeletal system
Knee Joint
Sports medicine
Cost-Benefit Analysis
medicine.medical_treatment
Prom
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Orthopedics and Sports Medicine
Prospective Studies
030212 general & internal medicine
Range of Motion
Articular
Arthroplasty
Replacement
Knee
Prospective cohort study
Randomized Controlled Trials as Topic
Novel designs
030222 orthopedics
Equipment Design
Middle Aged
Osteoarthritis
Knee
Functional outcome
Total knee replacement
Treatment Outcome
Female
Knee osteoarthritis
Knee Prosthesis
musculoskeletal diseases
medicine.medical_specialty
Joint replacement
Visual analogue scale
Kirurgia
anestesiologia
tehohoito
radiologia - Surgery
anesthesiology
intensive care
radiology
Arthroplasty
03 medical and health sciences
Double-Blind Method
Rheumatology
medicine
Humans
Aged
business.industry
Clinical protocols
Physical therapy
lcsh:RC925-935
business
Prospective studies
Oxford knee score
Zdroj: BMC Musculoskeletal Disorders
BMC Musculoskeletal Disorders, Vol 20, Iss 1, Pp 1-8 (2019)
Popis: BackgroundThe development of total knee replacement (TKR) implant designs aims to improve outcome regarding pain, function, joint stiffness, instability, patellar problems, and ultimately wear of the implant. Recently, two major orthopaedic implant manufacturers launched a new generation of TKR implants which, according to the manufacturers, provide improved functional outcome. However, the benefits of these new TKR designs claimed by the manufacturers in terms of improved functional outcome still lack scientific documentation. The present randomized controlled trial has been designed to compare three fixed bearing, cemented cruciate-retaining (CR) designs; one of the new personalized TKR design with two conventional TKR designs with the main emphasis being on functional outcome.MethodsThe present study is a prospective, double-blinded, randomized, single-center intervention trial. A total of 240 patients will be recruited to participate in a parallel-group study at Coxa Hospital for Joint Replacement, Tampere, Finland. We will compare the short-term functional outcome of TKR performed with a novel personalized TKR design (Persona CR, Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC CR, DePuy, Warsaw, IN, USA and Nexgen CR, Zimmer, Warsaw, IN, USA). In total, 80 patients will be randomized in each of the three study arms. The primary outcome in this study is the Oxford Knee Score (OKS), which is a validated patient-reported outcome measure (PROM). Secondary outcome measures include the Forgotten Joint Score, the 15D, the UCLA activity score, and the VAS pain scale. The results will be analyzed after 2-year follow-up.DiscussionThis paper presents a prospective, randomized, single-center trial study protocol. It provides details of patient randomization, PROMs, follow-up, methods of analysis of the material, and publication plan. An important aspect that will be considered in the study will be the economic effects of the novel designs as they are substantially more expensive, and the benefits of the added costs remain unknown. In addition, it is especially important to carry out evaluative studies in independent centers that are not biased by the interests of the manufacturers.Trial registrationRetrospectively registered, November, 2017,ClinicalTrials.govIdentifier:NCT03339557.
Databáze: OpenAIRE
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