Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome: a Randomised Controlled Trial

Canisius-Wilhelmina Hospital1 site in 1 country40 target enrollmentOctober 12, 2023

ConditionsPatellofemoral Pain Syndrome Tibial Tubercle Transfer Home Exercise Program

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patellofemoral Pain Syndrome
Sponsor: Canisius-Wilhelmina Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: Visual analogue pain score (VAS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 12, 2023

End Date

October 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Canisius-Wilhelmina Hospital

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Visual analogue pain score (VAS)

Time Frame: 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 Outcomes

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)
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)
Knee functionality using Decline step down test (DSDT)(baseline and after 26 weeks)
Kujala pain score(baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year)
Visual analogue pain score (VAS)(after 6 weeks, 26 weeks, and 1 year)
Tegner Activity Score(baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year)