Abstract
We compared an uncemented joint replacement (Elektra) with trapeziectomy (with ligament reconstruction and tendon interposition, LRTI) for the treatment of primary osteoarthritis in the first carpometacarpal joint (CMC1) in a randomised controlled trial. Forty patients were included (20 in each group) and followed for 2 years. The median age in the groups was 64 and 61, respectively, with 14 females in each. At final follow-up, there was no difference in the primary outcome measure (the quick disabilities of the arm, shoulder and hand score, QDASH), but the joint replacement group had significantly better motion and strength during the early rehabilitation period and significantly better range of thumb abduction and extension at the last follow-up. There were more complications in the joint replacement group with revision of prosthetic components in five cases, two of them due to cup loosening. Radiologically, lucency zones were seen around either cup or stem in 15 patients. Most were small, but two cases with major osteolysis resulted in revision. Shortening of the thumb ray was observed after trapeziectomy.
Trial registration: ClinicalTrials.gov identifier: NCT02556515.
Acknowledgements
Physiotherapists Bjørg Johanna Bolstad, Cathrine Myhre and Åse Marie Lier for their patience and assistance with evaluation and scoring of all patients;
Are Hugo Pripp, Professor, Oslo Centre of Biostatistics and Epidemiology, Oslo University Hospital for help with, and review of statistical methods;
Øystein Horgmo, University of Oslo for help with preparation of the figures in the article.
Ethical approval
Permission to perform this clinical trial was granted from the Regional Ethics Committee of South-Eastern Norway (276-08457c dated 18.08.08) and the local institutional ethics committee (07/3561, dated 19.6.08). The study was carried out in accordance with the Helsinki declaration, and it was registered and approved by ClinicalTrials.gov (NCT02556515). Patients gave written consent after receiving verbal and written information.
Disclosure statement
The authors declare no potential conflict of interests with respect to the research, authorship and/or publication of this article.