SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE)

Background: Patellofemoral pain (PFP) is a common musculoskeletal disorder resulting in anterior knee pain. Physiotherapy is the current standard treatment, while surgical intervention (tibial tubercle transfer [TTT]) is reserved for chronic cases when nonoperative treatment has failed. However, to date, no randomized controlled trials (RCT) have compared TTT combined with a physiotherapy (PT) program PT to PT alone as the initial treatment for PFP. Methods: A single-centre RCT in patients with chronic PFP (>1 year) will be randomized to either TTT followed by PT (n=20) or to PT alone (n=20). The primary outcome is knee pain at 18 weeks for the TTT group and at 12 weeks for the PT group, measured by the visual analog scale (VAS). Secondary outcomes include Patient Recorded Outcome Measures (PROMs) using the Kujala score, International Knee Documentation Committee (IKDC) ‘Subjective Knee Form’, Tegner Activity score and EuroQol 5D-5L for quality of life. Range of motion (ROM) is measured using the decline step-down test (DSDT). The difference in direct medical costs will also be assessed. Discussion: The REVITALISE study is the first randomized study to compare surgical intervention (TTT) followed by PT to PT alone in patients with chronic PFP. This study will generate level-1 evidence on the most effective treatment for chronic PFP, which can be integrated into the national guideline to aid orthopaedic surgeons and physiotherapists in their decision-making and ultimately improve our care for patients with chronic PFP. Trial registration Study Identifier NCT06227806, registered on 26 Jan 2024 on ClinicalTrials.gov. The study underwent independent peer review and received approval from the ethical review board (number NL80956.091.22).