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Comparative Study
. 2025 Jan 15;26(1):53.
doi: 10.1186/s12891-024-08226-y.

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

Myrthe P F van de Ven  1 , Martin Ophey  2 , Victor van de Graaf  3 , Sebastiaan A W van de Groes  4 , Marijn Sinkeldam  1 , Charlotte H W Wijers  5 , Sander Koëter  6
Affiliations
Comparative Study

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

Myrthe P F van de Ven et al. BMC Musculoskelet Disord. .

Abstract

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. TTT can result in clinically meaningful improvement in patients with patellofemoral maltracking without instability. However, to date, no randomised controlled trials (RCT) have compared TTT combined with a physiotherapy (PT) programme to PT alone as the initial treatment for PFP.

Methods: A single-centre nonblinded RCT in 40 patients with chronic PFP (> 1 year) and tibial tubercle-trochlear groove (TT-TG) > 15 mm will be randomised to either TTT followed by PT or to PT alone in a 1:1 ratio in a concealed manner. The primary outcome is knee pain at 18 weeks for the TTT group (6 weeks splint phase + 12 weeks PT) and at 12 weeks for the PT group, measured by the visual analog scale (VAS). Secondary outcomes include Patient-Reported Outcome Measures (PROMs) using the Kujala score, International Knee Documentation Committee (IKDC) 'Subjective Knee Form', Tegner Activity score and EuroQol 5D-5 L for quality of life. Range of motion (ROM) is measured using the decline step-down test (DSDT). Between-group differences will be analysed using multivariable linear regression analysis, while longitudinal differences will be assessed with linear mixed models for repeated measures. The difference in direct medical costs will also be assessed.

Discussion: The REVITALISE study is the first randomised 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).

Keywords: Patellofemoral pain; Physiotherapy; Randomised controlled trial; Tibial tubercle transfer.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was approved by the independent Ethical Committee METC Oost-Nederland (protocol number NL80956.091.22) and was registered on ClinicalTrials.gov (study identifier NCT06227806). Written informed consent will be provided by each participant before the start of the study assessments or the intervention. Consent for publication: The patient data that will be published are stated in the informed consent. The Dutch consent form for this trial is available as a supplementary material (see Supplementary file 2). Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the study protocol and procedures
See this image and copyright information in PMC

References

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