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

Canisius-Wilhelmina Hospital

Status: Enrolling

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

Treatments: Procedure: Home Exercise Program; Procedure: Tibial Tubercle Transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT06227806

NL80956.091.22

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tibial Tubercle Transfer surgery

Experimental group

Description:

Tibial Tubercle Transfer surgery followed by a home exercise program.

Treatment:

Procedure: Tibial Tubercle Transfer

Home Exercise Program

Active Comparator group

Description:

A home exercise program.

Treatment:

Procedure: Home Exercise Program