Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome (REVITALISE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patellofemoral Pain Syndrome; Tibial Tubercle Transfer; Home Exercise Program
• Intervention / Treatment: Procedure: Tibial Tubercle Transfer; Procedure: Home Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sander Koëter, PhD; Phone Number: 024-365 8265; Email: s.koeter@cwz.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500
      • Recruiting
      • Canisius Wilhelmina Hospital
      • Contact: Sander Koëter, PhD; Email: s.koeter@cwz.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tibial Tubercle Transfer surgery; Tibial Tubercle Transfer surgery followed by a home exercise program.	Procedure: Tibial Tubercle Transfer; Patients will receive the TTT surgery followed by a home exercise program.
Active Comparator: Home Exercise Program; A home exercise program.	Procedure: Home Exercise Program; Patients will receive an extensive home exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Canisius-Wilhelmina Hospital
• Investigators: Principal Investigator: Sander Koëter, PhD, Canisius-Wilhelmina Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: NL80956.091.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial protocol is available from the corresponding author on reasonable request. Data will be handled according to the FAIR principles. After completion of the study, metadata will be available upon request. For access to participant level-data and statistical code, an application can be submitted to the corresponding author.
• IPD Sharing Time Frame: After publication of the results of the study in a scientific article, data will become available for 15 years.
• IPD Sharing Access Criteria: Reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No