An interventional study of Tibial Tubercle Transfer and Home Exercise Program in Patellofemoral Pain Syndrome, Tibial Tubercle Transfer and Home Exercise Program, sponsored by Canisius-Wilhelmina Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Canisius-Wilhelmina Hospital · Not applicable, Interventional, and Treatment
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.
297 studies on the registry are indexed under Patellofemoral Pain Syndrome; 74 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 244 interventional studies indexed under Patellofemoral Pain Syndrome.
Browse Patellofemoral Pain Syndrome studies →Canisius-Wilhelmina Hospital is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Reported knee ligamentous or meniscal injuries;
Tibial Tubercle Transfer surgery followed by a home exercise program.
Procedure: Tibial Tubercle Transfer
A home exercise program.
Procedure: Home Exercise Program
Patients will receive the TTT surgery followed by a home exercise program.
Patients will receive an extensive home exercise program.
Visual analogue pain score (VAS)
10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.
Time frame: baseline and 12 weeks after HEP or 18 weeks after TTT surgery
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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and after 26 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, 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.
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Patellofemoral Pain Syndrome →
Canisius-Wilhelmina Hospital