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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Sander Koëter, PhD

Data sourced from clinicaltrials.gov

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