Clinical trial NCT06227806: Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome
Official title: Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Tibial Tubercle Transfer
Home Exercise Program
Lead sponsor: Canisius-Wilhelmina Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue pain score (VAS)
timeFrame: baseline and 12 weeks after HEP or 18 weeks after TTT surgery
Secondary outcomes:
measure: Kujala pain score
timeFrame: baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
measure: International Knee Documentation Committee Subjective Knee Form (IKDC)
timeFrame: baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
measure: Tegner Activity Score
timeFrame: baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
measure: EuroQol health-related quality of life (EQ-5D-5L) questionnaire
timeFrame: baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
measure: Visual analogue pain score (VAS)
timeFrame: after 6 weeks, 26 weeks, and 1 year
measure: Knee functionality using Decline step down test (DSDT)
timeFrame: baseline and after 26 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
Study officials:
affiliation: Canisius-Wilhelmina Hospital
name: Sander Koëter, PhD
role: PRINCIPAL_INVESTIGATOR
References: