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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial Tubercle Transfer surgery | Experimental | Tibial Tubercle Transfer surgery followed by a home exercise program. |
|
| Home Exercise Program | Active Comparator | A home exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibial Tubercle Transfer | Procedure | Patients will receive the TTT surgery followed by a home exercise program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Kujala pain score | The Kujala Score or Anterior Knee Pain Scale (AKPS) is a 13-item questionnaire to evaluate subjective symptoms and functional limitations in patients with PFP. The AKPS is graded on a scale of 0-100, with 100 reflecting no signs of PFP. | baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Previous knee surgery;
Reported knee ligamentous or meniscal injuries;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sander Koëter, PhD | Contact | 024-365 8265 | s.koeter@cwz.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sander Koëter, PhD | Canisius-Wilhelmina Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius Wilhelmina Hospital | Recruiting | Nijmegen | Gelderland | 6500 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39815178 | Derived | 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. |
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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.
After publication of the results of the study in a scientific article, data will become available for 15 years.
Reasonable request.
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Home Exercise Program | Procedure | Patients will receive an extensive home exercise program. |
|
| International Knee Documentation Committee Subjective Knee Form (IKDC) | The IKDC is a tool containing 7 items on knee symptoms, 2 on function, and 2 on sports activities, resulting in a score from 0-100, with 100 reflecting the highest level of pain and functional restrictions. | baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year |
| Tegner Activity Score | The Tegner Activity Score consists of 1 item, scoring the level of work- and sport activities, which is scored by a 10-point scale with 10 reflecting high level of activity. | 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 | The health-related quality of life (EQ-5D-5L) questionnaire consists of states of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are scored on 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). An index value will be calculated to reflect health state on a scale of 0 to 1, where 1 represents maximum quality of life. | baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year |
| Visual analogue pain score (VAS) | 10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain. | after 6 weeks, 26 weeks, and 1 year |
| Knee functionality using Decline step down test (DSDT) | The DSDT is a performance test simulating stair descent. It assesses maximum pain-free flexion angle, from 0 to 90 degrees. Larger angles reflect higher functionality of the knee. | baseline and after 26 weeks |