Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

— REVITALISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06227806
• Other study ID #: NL80956.091.22
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2024
• Source: Canisius-Wilhelmina Hospital
• Contact: Sander Koëter, PhD
• Phone: 024-365 8265
• Email: s.koeter[@]cwz.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Tibial Tubercle Transfer
Patients will receive the TTT surgery followed by a home exercise program.
• Home Exercise Program
Patients will receive an extensive home exercise program.

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Hospital	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Canisius-Wilhelmina Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue pain score (VAS)	10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.	baseline and 12 weeks after HEP or 18 weeks after TTT surgery
Secondary	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.	baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Secondary	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.	baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Secondary	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.	baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Secondary	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.	baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Secondary	Visual analogue pain score (VAS)	10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.	after 6 weeks, 26 weeks, and 1 year
Secondary	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.	baseline and after 26 weeks