Does cooled radiofrequency ablation improve postoperative pain and function in patients undergoing total knee replacement surgery? A randomized controlled trial.

Not Applicable

• Conditions: Osteoarthritis; Total knee arthroplasty; Surgery - Other surgery; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12620000310965
• Lead Sponsor: Department of Orthopaedics, Royal Hobart Hospital.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Elective primary unilateral TKR surgery performed by A/Prof Paul Harvie
- Diagnosis of knee osteoarthritis
- Age 18-85 years
- Provide consent to participate in the study and comply with the study protocol

Exclusion Criteria

- Patients who have had previous osteotomies or fractures of the distal femur or proximal tibia
- Unwillingness or inability to comply with study protocol or follow up requirements
- Subjects taking regular (daily) opiate medication pre-operatively
- Subjects with moderate or severe psychiatric illness
- Subjects deemed by the anaesthetist as not suitable for a general anaesthetic
- Any contraindication to the routine postoperative analgesic medication regimen as outlined in the study protocol or deemed by the anaesthetist to be not suitable for this regimen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and functional result assessed via the Western Ontario and McMaster Universities Index (WOMAC) score.[This will be assessed at post-operative weeks 2, 6 and 12 (primary timepoint). The WOMAC is a 24-item questionnaire with 3 sub-scales measuring pain, stiffness and physical function. The WOMAC has been validated for measuring outcomes in clinical trials of TKR and takes approximately 10 minutes to complete. This will be completed by a designated assessor at outpatient clinic appointments at the 2, 6 and 12 week mark. ];Patient-reported pain scores assessed using the 0-100 Visual Analogue Scale for Pain (VAS Pain).[3 months post surgery. This will be assessed at post-operative day 1, post-operative day 2, and weeks 2, 6 and 12 (primary timepoint).]