Effects of 6 weeks of cryotherapy plus compression therapy after total or unicompartmental knee arthroplasty: protocol for a single-centre, single-blind randomised controlled trial.

Abstract

Effective rehabilitation after total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA) is often impeded by pain and swelling. Beneficial short-term effects in terms of pain and opioid use after a short period of cryotherapy (±compression therapy) have been demonstrated. The effectiveness of a longer intervention period on longer-term postoperative outcomes is unclear. This study aims to assess the effects of 6 weeks of cryotherapy plus compression therapy on pain, functioning and patient satisfaction after TKA or UKA. A single-centre, single-blind randomised controlled trial will be conducted at a teaching hospital in the Netherlands. Patients over age 18 with end-stage osteoarthritis planned for a TKA or UKA are eligible; 104 UKA and 104 TKA patients will be included. Both groups will be randomly allocated (1:1) into an intervention group receiving 6 weeks of cryotherapy plus compression therapy (commencing after discharge from hospital) or a control group (usual care). The primary endpoint is perceived pain at rest at 6 weeks postoperatively. Secondary outcomes include compliance with cold protocol, pain at rest during the first six postoperative weeks and at 6 and 12 months postoperatively, pain on weight bearing, opioid use, functioning, patient satisfaction and complications. The local medical ethics committee MEC-U approved the study protocol (R22.095/NL-number NL81956.100.22). The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice regulations, and personal data will be handled in agreement with the Dutch Personal Data Protection Act (AGV). Written informed consent will be obtained prior to performing any of the study procedures. We will disseminate study results through multiple peer-reviewed publications and through conference presentations. NCT05572359.