Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome

Not Applicable

Recruiting

• Conditions: Home Exercise Program; Patellofemoral Pain Syndrome; Tibial Tubercle Transfer
• Interventions: Procedure: Tibial Tubercle Transfer; Procedure: Home Exercise Program

• Registration Number: NCT06227806
• Lead Sponsor: Canisius-Wilhelmina Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-12
• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tibial Tubercle Transfer surgery	Tibial Tubercle Transfer	Tibial Tubercle Transfer surgery followed by a home exercise program.
Home Exercise Program	Home Exercise Program	A home exercise program.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands