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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will receive the TTT surgery followed by a home exercise program.
Patients will receive an extensive home exercise program.
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
RECRUITINGVisual 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
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