Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome

NCT ID: NCT06227806

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patellofemoral Pain Syndrome Tibial Tubercle Transfer Home Exercise Program

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tibial Tubercle Transfer surgery

Tibial Tubercle Transfer surgery followed by a home exercise program.

Group Type EXPERIMENTAL

Tibial Tubercle Transfer

Intervention Type PROCEDURE

Patients will receive the TTT surgery followed by a home exercise program.

Home Exercise Program

A home exercise program.

Group Type ACTIVE_COMPARATOR

Home Exercise Program

Intervention Type PROCEDURE

Patients will receive an extensive home exercise program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tibial Tubercle Transfer

Patients will receive the TTT surgery followed by a home exercise program.

Intervention Type PROCEDURE

Home Exercise Program

Patients will receive an extensive home exercise program.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sander Koëter, PhD

Role: PRINCIPAL_INVESTIGATOR

Canisius-Wilhelmina Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sander Koëter, PhD

Role: CONTACT

024-365 8265

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sander Koëter, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

van de Ven MPF, Ophey M, van de Graaf V, van de Groes SAW, Sinkeldam M, Wijers CHW, Koeter S. Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE). BMC Musculoskelet Disord. 2025 Jan 15;26(1):53. doi: 10.1186/s12891-024-08226-y.

Reference Type DERIVED
PMID: 39815178 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL80956.091.22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.