Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE)
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...
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2025-01-01
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| Series: | BMC Musculoskeletal Disorders |
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| Online Access: | https://doi.org/10.1186/s12891-024-08226-y |
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| author | Myrthe P. F. van de Ven Martin Ophey Victor van de Graaf Sebastiaan A. W. van de Groes Marijn Sinkeldam Charlotte H. W. Wijers Sander Koëter |
| author_facet | Myrthe P. F. van de Ven Martin Ophey Victor van de Graaf Sebastiaan A. W. van de Groes Marijn Sinkeldam Charlotte H. W. Wijers Sander Koëter |
| author_sort | Myrthe P. F. van de Ven |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-6b62ee483a4f4e62a62bc95bdfc26a32 |
| institution | Kabale University |
| issn | 1471-2474 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
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| series | BMC Musculoskeletal Disorders |
| spelling | doaj-art-6b62ee483a4f4e62a62bc95bdfc26a322025-01-19T12:04:32ZengBMCBMC Musculoskeletal Disorders1471-24742025-01-0126111010.1186/s12891-024-08226-yTibial 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 Ven0Martin Ophey1Victor van de Graaf2Sebastiaan A. W. van de Groes3Marijn Sinkeldam4Charlotte H. W. Wijers5Sander Koëter6Department of Orthopaedics, Canisius Wilhelmina ZiekenhuisDepartment of Orthopaedic Surgery and Sports Medicine, Amsterdam UMCDepartment of Orthopaedic Surgery, Bergman ClinicsDepartment of Orthopaedics, Radboud University Medical CentreDepartment of Orthopaedics, Canisius Wilhelmina ZiekenhuisCWZ Academy, Canisius Wilhelmina ZiekenhuisDepartment of Orthopaedics, Canisius Wilhelmina ZiekenhuisAbstract 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).https://doi.org/10.1186/s12891-024-08226-yPatellofemoral painTibial tubercle transferPhysiotherapyRandomised controlled trial |
| spellingShingle | Myrthe P. F. van de Ven Martin Ophey Victor van de Graaf Sebastiaan A. W. van de Groes Marijn Sinkeldam Charlotte H. W. Wijers Sander Koëter Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE) BMC Musculoskeletal Disorders Patellofemoral pain Tibial tubercle transfer Physiotherapy Randomised controlled trial |
| title | Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE) |
| title_full | Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE) |
| title_fullStr | Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE) |
| title_full_unstemmed | Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE) |
| title_short | Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE) |
| title_sort | tibial tubercle transfer surgery and physiotherapy versus physiotherapy only for chronic patellofemoral pain study protocol for a randomised controlled trial revitalise |
| topic | Patellofemoral pain Tibial tubercle transfer Physiotherapy Randomised controlled trial |
| url | https://doi.org/10.1186/s12891-024-08226-y |
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