Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome
REVITALISE
1 other identifier
interventional
40
1 country
1
Brief Summary
The goal of this randomised controlled trial is to compare a tuberositas transposition (TTT) surgery with a home exercise program (HEP) in patients with patellofemoral pain syndrome (PFPS). The study aims to evaluate the efficiency of TTT in conjunction with a HEP compared to a HEP alone in patients with chronic PFPS. Participants will randomly be allocated to the surgery or HEP group. Researchers will compare the surgery and HEP groups to see if activity-related pain and patient reported outcome measures (PROMs) are different.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2023
CompletedFirst Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 29, 2024
January 1, 2024
2 years
January 9, 2024
January 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Visual analogue pain score (VAS)
10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.
baseline and 12 weeks after HEP or 18 weeks after TTT surgery
Secondary Outcomes (6)
Kujala pain score
baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
International Knee Documentation Committee Subjective Knee Form (IKDC)
baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Tegner Activity Score
baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
EuroQol health-related quality of life (EQ-5D-5L) questionnaire
baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Visual analogue pain score (VAS)
after 6 weeks, 26 weeks, and 1 year
- +1 more secondary outcomes
Study Arms (2)
Tibial Tubercle Transfer surgery
EXPERIMENTALTibial Tubercle Transfer surgery followed by a home exercise program.
Home Exercise Program
ACTIVE COMPARATORA home exercise program.
Interventions
Patients will receive the TTT surgery followed by a home exercise program.
Patients will receive an extensive home exercise program.
Eligibility Criteria
You may qualify if:
- Characteristic history of PFPS (patellofemoral pain during knee loading physical activity, such as jumping, running, squatting);
- Symptoms lasting at least 12 months;
- Tibial tubercle trochlear groove (TT-TG) distance of 15mm or more on CT or MRI;
- Patellofemoral pain during daily life activities, such as: standing for an extended period, walking, or walking upstairs or downstairs
You may not qualify if:
- Previous knee surgery;
- Reported knee ligamentous or meniscal injuries;
- Disabling general illness;
- A history of patellar dislocation; however, subjects with patellar subluxation are included in the study;
- Other knee problems than PFPS diagnosed clinically (such as jumper's knee);
- Other knee problems than PFPS diagnosed radiographically (such as osteochondritis - dissecans);
- Patients who cannot undergo surgery;
- Pregnancy;
- Patients with inability to complete follow-up or with limited understanding of the Dutch language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6500, Netherlands
Related Publications (1)
van de Ven MPF, Ophey M, van de Graaf V, van de Groes SAW, Sinkeldam M, Wijers CHW, Koeter S. Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE). BMC Musculoskelet Disord. 2025 Jan 15;26(1):53. doi: 10.1186/s12891-024-08226-y.
PMID: 39815178DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sander Koëter, PhD
Canisius-Wilhelmina Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 29, 2024
Study Start
October 12, 2023
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
January 29, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After publication of the results of the study in a scientific article, data will become available for 15 years.
- Access Criteria
- Reasonable request.
The trial protocol is available from the corresponding author on reasonable request. Data will be handled according to the FAIR principles. After completion of the study, metadata will be available upon request. For access to participant level-data and statistical code, an application can be submitted to the corresponding author.