Patellofemoral Pain SyndromeREVITALISENCT06227806
Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome
A study testing Tibial Tubercle Transfer and Home Exercise Program in people with Patellofemoral Pain Syndrome and Tibial Tubercle Transfer, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Tibial Tubercle Transfer, Home Exercise Program
- What is being tested?
- Tibial Tubercle Transfer and Home Exercise Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Oct 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
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- Patients who cannot undergo surgery;
- Pregnancy;
- Patients with inability to complete follow-up or with limited understanding of the Dutch language
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6500
Sander Koëter, PhD, s.koeter@cwz.nl
About this study
Official title: 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.
- Being tested
- Tibial Tubercle Transfer, Home Exercise Program
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial Tubercle TransferProcedure or surgery
Patients will receive the TTT surgery followed by a home exercise program.
Home Exercise ProgramProcedure or surgery
Patients will receive an extensive home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Tibial Tubercle Transfer surgery | Experimental | Tibial Tubercle Transfer surgery followed by a home exercise program. Receives: Procedure: Tibial Tubercle Transfer |
| Home Exercise Program | Active comparator | A home exercise program. Receives: Procedure: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score (VAS)
10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.
Measured: baseline and 12 weeks after HEP or 18 weeks after TTT surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and after 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start12 Oct 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canisius-Wilhelmina Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sander Koëter, PhD, Principal investigator, Canisius-Wilhelmina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227806
- Sponsor's protocol ID
- NL80956.091.22
- Acronym
- REVITALISE
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39815178
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery and Exercise Versus Exercise Only for Chronic Patellofemoral Pain Syndrome: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06227806
- Acronym / sponsor ID
- REVITALISE / NL80956.091.22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Canisius-Wilhelmina HospitalUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibial Tubercle Transfer surgery | Experimental | Procedure: Tibial Tubercle TransferTibial Tubercle Transfer surgery followed by a home exercise program. |
| Home Exercise Program | Active comparator | Procedure: Home Exercise ProgramA home exercise program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Previous knee surgery;
- Reported knee ligamentous or meniscal injuries;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibial Tubercle TransferPatients will receive the TTT surgery followed by a home exercise program. | Procedure or surgery | Tibial Tubercle Transfer surgery |
| Home Exercise ProgramPatients will receive an extensive home exercise program. | Procedure or surgery | Home Exercise Program |
Primary outcome
Visual analogue pain score (VAS)
Time frame: baseline and 12 weeks after HEP or 18 weeks after TTT surgery
10-cm (0-10) visual VAS to assess activity-related pain. Higher scores reflect higher pain.
6 secondary outcomes
Kujala pain score
Time frame: 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)
Time frame: baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Tegner Activity Score
Time frame: 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
Time frame: baseline, after 12 weeks after HEP or 18 weeks after TTT surgery, 26 weeks, and 1 year
Visual analogue pain score (VAS)
Time frame: after 6 weeks, 26 weeks, and 1 year
Knee functionality using Decline step down test (DSDT)
Time frame: baseline and after 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 39815178van 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sander Koëter, PhD principal investigator
Canisius-Wilhelmina Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial Tubercle Transfer and Home Exercise Program in people with Patellofemoral Pain Syndrome and Tibial Tubercle Transfer, run by Canisius-Wilhelmina Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sander Koëter, PhD (024-365 8265, s.koeter@cwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain score (VAS) (time frame: baseline and 12 weeks after HEP or 18 weeks after TTT surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.