Clinical Trials in Orthopedic Disorders

STUDY PROTOCOL
Year
: 2018  |  Volume : 3  |  Issue : 3  |  Page : 74--80

Comparing unicompartmental to total knee arthroplasty in medial gonarthritis: study protocol for 2-year follow-up of a randomized controlled trial


Carl Aulin, Nicolas Martinez-Carranza, Johan Fyhrlund, Hans E Berg, Margareta Hedström 
 Institution of Clinical Sciences, Intervention and Technology (CLINTEC) Karolinska Institutet; Department of Orthopedics, Karolinska University Hospital, SE-141 86, Stockholm, Sweden

Correspondence Address:
Carl Aulin
Institution of Clinical Sciences, Intervention and Technology (CLINTEC) Karolinska Institutet; Department of Orthopedics, Karolinska University Hospital, SE-141 86, Stockholm
Sweden

Background and objectives: Since the 1990s, unicompartmental knee arthroplasty (UKA) are again starting to gain interest worldwide. A mere 3.5% of all knee arthroplasties performed in Sweden 2014 were UKAs, whereas up to 25% had knee osteoarthritis isolated to the medial side. Reasons for this discrepancy might be that UKAs are considered more technically demanding, thus requiring more surgical training, and that long-term survival of these implants has been inferior compared to total knee arthroplasty (TKA). This has been addressed by improving surgical instruments and discontinuation of underperforming implants, and by improving surgical technique including mini-invasive incision and patient selection. In support of using the less surgically invasive UKA, a few cohort studies show less pain, fewer hospital days, and faster rehabilitation. However, to the best of our knowledge, there is a lack of high quality randomized clinical trials (RCTs) showing unequivocal clinical superiority of UKA compared to TKA. The aim of the present study is to compare changes in muscle mass, strength, performance based measures (PBMs), and patient reported outcome measures (PROMs) in patients randomized to UKA or TKA. Design: A 2-year follow-up RCT. Methods: The study will include 80 patients with medial knee osteoarthritis, aged 50 years or more, who will be scheduled for a knee replacement and equally randomized to either TKA or UKA. Outcome measures: The primary outcome is muscle mass change at 6 weeks, 6, 12 and 24 months post-operatively measured by computed tomography. Secondary outcomes are PBMs, PROMs, muscle strength, and 3D motion analysis at the same occasions. Discussion: Although patients subjected to total hip arthroplasty are typically satisfied with their surgical results, patients with TKA are less so. It is of importance to improve surgical procedure, and less invasive surgery of the knee might be a solution. Ethics and dissemination: The study has been approved by the Regional Ethics Committee in Stockholm (DNR: 2014/1895-31/3) and will be conducted in accordance with the ethical principles of the Declaration of Helsinki. All patients will sign a consent form after being given oral and written information of the study. Patient recruitment began in November 2015 and will end in December 2019. Data collection will complete in June 2021. We plan to present results in open access scientific publications and at scientific conferences and meetings. Trial registration: The study protocol was registered with ClinicalTrials.gov (identifier: NCT 02563756) on September 18, 2015. Protocol version: 1.0.


How to cite this article:
Aulin C, Martinez-Carranza N, Fyhrlund J, Berg HE, Hedström M. Comparing unicompartmental to total knee arthroplasty in medial gonarthritis: study protocol for 2-year follow-up of a randomized controlled trial.Clin Trials Orthop Disord 2018;3:74-80


How to cite this URL:
Aulin C, Martinez-Carranza N, Fyhrlund J, Berg HE, Hedström M. Comparing unicompartmental to total knee arthroplasty in medial gonarthritis: study protocol for 2-year follow-up of a randomized controlled trial. Clin Trials Orthop Disord [serial online] 2018 [cited 2020 Apr 7 ];3:74-80
Available from: http://www.clinicalto.com/article.asp?issn=2542-4157;year=2018;volume=3;issue=3;spage=74;epage=80;aulast=Aulin;type=0