Home Exercise Program, Patellofemoral Pain Syndrome, Tibial Tubercle Transfer
Conditions
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.
Interventions
PROCEDURETibial Tubercle Transfer
Patients will receive the TTT surgery followed by a home exercise program.
PROCEDUREHome Exercise Program
Patients will receive an extensive home exercise program.
Sponsors
Canisius-Wilhelmina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue pain score (VAS) | baseline and 12 weeks after HEP or 18 weeks after TTT surgery | 10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Tegner Activity Score | baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year | 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. |
| Kujala pain score | baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year | 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. |
| Visual analogue pain score (VAS) | after 6 weeks, 26 weeks, and 1 year | 10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain. |
| Knee functionality using Decline step down test (DSDT) | baseline and after 26 weeks | 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. |
| 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 | 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. |
Countries
Netherlands
Contacts
Primary ContactSander Koëter, PhD
Outcome results
None listed