Calcaneus FracturePIONEERNCT05721378
Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
A study testing Permissive Weight Bearing group and Restricted Weight Bearing group in people with Calcaneus Fracture and Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), run by Maastricht University Medical Center at 11 sites in Netherlands.
Trial summary
The goal of the proposed study is to define the optimal rehabilitation for trauma patients with Displaced Intra-articular Calcaneal Fractures, either Permissive Weight Bearing (PWB) or Restricted Weight Bearing (RWB) regarding functional outcomes, health related quality of life, radiographical differences… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Calcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), Trauma Injury
- What is being tested?
- Permissive Weight Bearing group and Restricted Weight Bearing group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 11 sitesNetherlands
- Study dates
- 1 Jul 2024to 1 Jan 2026
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgically treated trauma patients with isolated unilateral DIACFs, less than 6 weeks after trauma, Sanders type II-IV (14)
- Age between 18 and 67 years old (labor force)
- Being able to understand the questionnaires and measurement instructions
- Indication for open/closed reduction and internal fixation
- Written Informed Consent
Who cannot join
- Acute or existing amputation (upper limb, lower limb, feet)
- Open calcaneal fractures (excluding medial wound without compromising surgical approach)
- Bilateral fractures of the lower extremities
- Unable to comply to the PWB protocol due to pre-existing conditions of the arms and legs (e.g. unable to use crotches due to hemiparalysis)
- Severe non-fracture related comorbidity of the lower extremity
- Pre-existent immobility (loss of muscle function of one or both legs)
Show all 14Show fewer
- Dependent in activities of daily living (e.g. due to dementia, Alzheimer, New York Heart Association class IV angina, heart failure or oxygen-dependent chronic obstructive pulmonary disease)
- Rheumatoid arthritis of the lower extremities
- Severe psychiatric comorbidities that lead to inability to comply with the treatment protocol
- Pathologic fractures (metastasis, secondary osteoporosis)
- Peripheral neuropathy and/or diabetes
- Alcohol- or drug abuse preventing adequate follow-up
- Primary indication for arthrodesis subtalar joint
- Two or more fractures of the upper and/or lower extremities
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Not yet recruiting
Amsterdam University Medical Center
Amsterdam
Tim Schepers, MD
- Not yet recruiting
Rijnstate Hospital
Arnhem
Albert Pull ter Gunne, MD
- Not yet recruiting
Amphia Hospital
Breda
Niels Berende, MD
- Not yet recruiting
Catharina Hospital
Eindhoven
Alexander van der Veen, MD
- Not yet recruiting
Groene Hart Hospital
Gouda
Jan Siert Reinders, MD
- Recruiting
Maastricht University Medical Center +
Maastricht
Martijn Poeze, Prof.
- Recruiting
Radboud University Medical Center
Nijmegen
Erik Hermans, MD
- Not yet recruiting
Maasstad Hospital
Rotterdam
Kees van der Vlies, MD
- Not yet recruiting
Zuyderland Medical Center
Sittard
Raoul van Vugt, MD
- Not yet recruiting
Haaglanden Medical Center
The Hague
Jochem Hoogendoorn, MD
- Not yet recruiting
Elisabeth-Twee Steden Hospital
Tilburg
Hilco Theeuwes, MD
About this study
Official title: (Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
The goal of the proposed study is to define the optimal rehabilitation for trauma patients with Displaced Intra-articular Calcaneal Fractures, either Permissive Weight Bearing (PWB) or Restricted Weight Bearing (RWB) regarding functional outcomes, health related quality of life, radiographical differences, cost-effectiveness and complications.
Read the detailed description
Rationale: Of all fractures, 1-2% involve the calcaneus. Often surgical treatment is needed. Even after successful treatment it requires long rehabilitation with major impact on daily life and socio-economic aspects. Anatomic surgical restoration does not prevent gait disturbances or persistent foot pain. An adequate rehabilitation program is mandatory to maximize foot stability.
Objective: Evidence showing which rehabilitation protocol is best for both fracture healing and quality of life for patients with Displaced Intra-Articular Calcaneal Fractures (DIACFs) is mostly lacking. This study has the aim to answer the question whether surgically treated patients with DIACFs following the Permissive Weight Bearing protocol (PWB) have better functional outcomes compared to patients with Restricted Weight Bearing protocol after 12 weeks (RWB) measured with the American Orthopaedic Foot \& Ankle Society (AOFAS) Score. The study hypothesizes that patients with DIACFs following the PWB protocol will have a better quality of life (HR-QOL) compared to patients who followed the RWB protocol.
The hypothesis is that there will be lower costs without any radiographic differences for surgically treated (irrespective of technique used) patients with DIACFs following a PWB protocol comparing to the current AO (Arbeitsgemeinschaft für Osteosynthesefragen) standard care: the RWB protocol.
Study design: Multi-center randomized controlled trial
Study population: Presence of surgically (extended lateral, sinus tarsi or percutaneous approach) fixed DIACFs classified as Sanders type II to IV, age 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. Patients will only be included after written informed consent is obtained.
Groups (intervention and control): Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.
Main study parameters/endpoints: Primary objective: functional outcome. Secondary outcomes: quality of life, differences in radiographic parameters, complications, cost effectiveness and differences in surgical techniques.
Nature and extent of the burden: The PWB protocol aims to restore weight bearing faster than RWB protocol in DIACFs. Early postoperative weight bearing poses the risk of increased complications, such as secondary displacement of the fracture or failure of fracture fixation. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate, although data from prospective randomized trials in calcaneus fractures are lacking. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks and 6 months. The radiation exposure will not be different from standard of care. Therefore, the burden for participants is considered minimal, with no significant health risks.
- Conditions
- Calcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), Trauma Injury
- Being tested
- Permissive Weight Bearing group, Restricted Weight Bearing group
- Keywords
- Permissive Weight Bearing, Rehabilitation
- Medical subject headings
- Disease, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permissive Weight Bearing groupProcedure or surgery
Also called Early Weight Bearing
The Permissive Weight Bearing (PWB) protocol allows earlier post-operative permissive weight bearing, where progression of weight bearing is guided by the subjective experience (for example: pain, weight bearing tolerance) of the patient and the clinical expertise of the treating physician and therapist. Patients allocated to the PWB protocol start weight bearing after wound healing is achieved (approximately two weeks after the operation). Consequently, patients are stimulated to bear as much weight as tolerated by pain and comfort. Treatment will take place according to the PROMETHEUS protocol (treatment- and evaluation protocol). The protocol contains a number of weight bearing milestones (e.g. walking with two crutches, walking with two canes, walking with one cane and walking without any walking aids). The treating physiotherapist or physician records the dates that these milestones are reached in the study database.
Restricted Weight Bearing groupProcedure or surgery
Also called Non Weight Bearing
The Restrictive Weight Bearing (RWB) protocol consists of 8 to 12 weeks of postoperative restricted weight (0-10%) bearing, following the current AO Guidelines (7). After 8 weeks of restricted weight bearing, the weight bearing will be increased with 25% per week for 4 weeks. Every time the patient and the treating physical therapist or physician have contact, the weight bearing advice given to the patient at that point in time is recorded (unloaded; partial weight bearing + clarification; full weight bearing). Also, any additional advice given to the patient is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Permissive Weight Bearing group | Experimental | Rehabilitation following the Permissive Weight Bearing (PWB) protocol Receives: Procedure: Permissive Weight Bearing group |
| Restrictive Weight Bearing group | Active comparator | Rehabilitation following the Restrictive Weight Bearing (RWB) protocol Receives: Procedure: Restricted Weight Bearing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional outcome as defined by the AOFAS questionnaire
The American Orthopaedic Foot \& Ankle Society (AOFAS) score is a clinician-based score. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. It is designed for physicians to help standardize the assessment of patients and makes the results of this study comparable with previous data. Scores range from 0 to 100, with healthy foot and ankles receiving 100 points.
Measured: 0, 2, 6, 12 weeks and 6 months post-surgery.
Secondary outcomes (7)
Self-reported function with the Maryland Foot Score
The MFS is an assessment for foot disorders, mainly consisting of the following items: pain, gait, functional activities, and cosmesis. The scale scores have a minimum of 0 points and a maximum of 100 points. A total score of <50 is considered as poor, 50-74 as fair, 75-89 as good, and 90-100 as excellent.
Measured: 0, 2, 6, 12 weeks and 6 months post-surgery
Activities of Daily Living (ADL) with LEFS
The lower extremity functional scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress, and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The questionnaire consists of 80 points. The lower the score the greater the disability.
Measured: 0, 2, 6, 12 weeks and 6 months post-surgery
Health Related Quality of Life with EQ-5D-5L
The EuroQol 5-Dimension, 5-Level Health Scale (EQ-5D-5L) is a self-administered questionnaire, which will be completed at baseline together with the cost questionnaire at the same moments (0, 2, 6, 12 weeks and 6 months). Both generic quality of life, as well as utilities, will be derived by means of the EQ-5D-5L, which will be administered both by the patients. The Dutch version of the EQ-5D-5L is chosen because it is a widely used quality of life instrument (nationally and internationally) and it is recommended by the Dutch guidelines.The EQ-5D-5L contains 5 dimensions of health-related quality of life, namely mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated at five levels: no problems to major problems. The 5 dimensions can be summed into a health state.
Measured: 0, 2, 6, 12 weeks and 6 months post-surgery
Böhlers angle and posterior facet joint
Radiographic evaluation by a radiologist blinded for treatment allocation will be done at the same time intervals as the scheduled visits to the physician.
To see if there is a difference in the alignment of Böhlers angle and posterior facet joint alignment (radiographically measured), a CT-scan will be performed early post-operatively (before first weight bearing) and after 6 months. Differences in the Böhlers angle and posterior joint alignment (Δ = CT6months - CTpost-op.) will be calculated. The normal degree for the Böhler angle varieties between 25° and 40°. An intra-articular step off or gap from less than 2mm of the posterior facet was considered as well-reduced.
Measured: Early postoperative (before first mobilization) and 6 months post-surgery
Medical consumption with iMCQ
The iMTA Medical Consumption Questionnaire (iMCQ) measures health care utilization and is based on 29 questions. It is an instrument for measuring medical consumption and is related to frequently occurring contacts with health care providers. The iMCQ is a generic questionnaire. It is therefore not disease specific. The questions ask about health care related appointments patients had in the past period. In case the respondent had no appointments, the score '0' is noted.
Measured: 0 weeks and 6 months post-surgery
Society costs with iPCQ
The iMTA Productivity Cost Questionnaire (iPCQ) measures productivity losses. The questionnaire is based on 12 questions. Questions 1 to 3 give information about the amount of paid work (in hours) and the number of days per week on which the respondent works. The latter provides insight into the average number of hours of work per working day of the respondent. This information is needed to calculate productivity loss costs.
The questions about productivity losses form the following modules:
- Absenteeism: absenteeism from paid work (questions 4 to 6)
- Presenteeism: productivity losses during days worked (questions 7 to 9)
- Productivity loss from unpaid work (questions 10 to 12). After completing the questionnaire the total amount of absenteeism can be calculated by multiplying the number of days absent and the number of hours per working day of the respondent.
To calculate the costs of productivity losses, volumes are multiplied by unit cost prices.
Measured: 0 weeks and 6 months post-surgery
Occurrence of complications
Most important complications, such as: wound infection, dislocation, non-union, - failure of osteosynthesis, postoperative arthritis
Measured: 6 and 12 weeks and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jan 2026 (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 Calcaneus FractureStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721378
- Sponsor's protocol ID
- PIONEER
- Acronym
- PIONEER
- Status last verified
- Oct 2024
- First submitted
- 13 Jan 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verstappen C, Driessen MLS, Kalmet PHS, Brandts L, Kimman M, Edwards M, Hermans E, Poeze M. Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial. Trials. 2024 Nov 18;25(1):778. doi: 10.1186/s13063-024-08617-5.
PubMed 39558368
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05721378
- Acronym / sponsor ID
- PIONEER / PIONEER
- Conditions
- Calcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), Trauma Injury
- Keywords
- Permissive Weight Bearing, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Feb 2023 (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 the proposed study is to define the optimal rehabilitation for trauma patients with Displaced Intra-articular Calcaneal Fractures, either Permissive Weight Bearing (PWB) or Restricted Weight Bearing (RWB) regarding functional outcomes, health related quality of life, radiographical differences, cost-effectiveness and complications.
Detailed description
Rationale: Of all fractures, 1-2% involve the calcaneus. Often surgical treatment is needed. Even after successful treatment it requires long rehabilitation with major impact on daily life and socio-economic aspects. Anatomic surgical restoration does not prevent gait disturbances or persistent foot pain. An adequate rehabilitation program is mandatory to maximize foot stability.
Objective: Evidence showing which rehabilitation protocol is best for both fracture healing and quality of life for patients with Displaced Intra-Articular Calcaneal Fractures (DIACFs) is mostly lacking. This study has the aim to answer the question whether surgically treated patients with DIACFs following the Permissive Weight Bearing protocol (PWB) have better functional outcomes compared to patients with Restricted Weight Bearing protocol after 12 weeks (RWB) measured with the American Orthopaedic Foot \& Ankle Society (AOFAS) Score. The study hypothesizes that patients with DIACFs following the PWB protocol will have a better quality of life (HR-QOL) compared to patients who followed the RWB protocol.
The hypothesis is that there will be lower costs without any radiographic differences for surgically treated (irrespective of technique used) patients with DIACFs following a PWB protocol comparing to the current AO (Arbeitsgemeinschaft für Osteosynthesefragen) standard care: the RWB protocol.
Study design: Multi-center randomized controlled trial
Study population: Presence of surgically (extended lateral, sinus tarsi or percutaneous approach) fixed DIACFs classified as Sanders type II to IV, age 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. Patients will only be included after written informed consent is obtained.
Groups (intervention and control): Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.
Main study parameters/endpoints: Primary objective: functional outcome. Secondary outcomes: quality of life, differences in radiographic parameters, complications, cost effectiveness and differences in surgical techniques.
Nature and extent of the burden: The PWB protocol aims to restore weight bearing faster than RWB protocol in DIACFs. Early postoperative weight bearing poses the risk of increased complications, such as secondary displacement of the fracture or failure of fracture fixation. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate, although data from prospective randomized trials in calcaneus fractures are lacking. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks and 6 months. The radiation exposure will not be different from standard of care. Therefore, the burden for participants is considered minimal, with no significant health risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permissive Weight Bearing group | Experimental | Procedure: Permissive Weight Bearing groupRehabilitation following the Permissive Weight Bearing (PWB) protocol |
| Restrictive Weight Bearing group | Active comparator | Procedure: Restricted Weight Bearing groupRehabilitation following the Restrictive Weight Bearing (RWB) protocol |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgically treated trauma patients with isolated unilateral DIACFs, less than 6 weeks after trauma, Sanders type II-IV (14)
- Age between 18 and 67 years old (labor force)
- Being able to understand the questionnaires and measurement instructions
- Indication for open/closed reduction and internal fixation
- Written Informed Consent
Key exclusion criteria (14 listed)
- Acute or existing amputation (upper limb, lower limb, feet)
- Open calcaneal fractures (excluding medial wound without compromising surgical approach)
- Bilateral fractures of the lower extremities
- Unable to comply to the PWB protocol due to pre-existing conditions of the arms and legs (e.g. unable to use crotches due to hemiparalysis)
- Severe non-fracture related comorbidity of the lower extremity
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 |
|---|---|---|
| Permissive Weight Bearing groupAlso: Early Weight BearingThe Permissive Weight Bearing (PWB) protocol allows earlier post-operative permissive weight bearing, where progression of weight bearing is guided by the subjective experience (for example: pain, weight bearing tolerance) of the patient and the clinical expertise of the treating physician and therapist. Patients allocated to the PWB protocol start weight bearing after wound healing is achieved (approximately two weeks after the operation). Consequently, patients are stimulated to bear as much weight as tolerated by pain and comfort. Treatment will take place according to the PROMETHEUS protocol (treatment- and evaluation protocol). The protocol contains a number of weight bearing milestones (e.g. walking with two crutches, walking with two canes, walking with one cane and walking without any walking aids). The treating physiotherapist or physician records the dates that these milestones are reached in the study database. | Procedure or surgery | Permissive Weight Bearing group |
| Restricted Weight Bearing groupAlso: Non Weight BearingThe Restrictive Weight Bearing (RWB) protocol consists of 8 to 12 weeks of postoperative restricted weight (0-10%) bearing, following the current AO Guidelines (7). After 8 weeks of restricted weight bearing, the weight bearing will be increased with 25% per week for 4 weeks. Every time the patient and the treating physical therapist or physician have contact, the weight bearing advice given to the patient at that point in time is recorded (unloaded; partial weight bearing + clarification; full weight bearing). Also, any additional advice given to the patient is recorded. | Procedure or surgery | Restrictive Weight Bearing group |
Primary outcome
Change in functional outcome as defined by the AOFAS questionnaire
Time frame: 0, 2, 6, 12 weeks and 6 months post-surgery.
The American Orthopaedic Foot \& Ankle Society (AOFAS) score is a clinician-based score. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. It is designed for physicians to help standardize the assessment of patients and makes the results of this study comparable with previous data. Scores range from 0 to 100, with healthy foot and ankles receiving 100 points.
7 secondary outcomes
Self-reported function with the Maryland Foot Score
Time frame: 0, 2, 6, 12 weeks and 6 months post-surgery
Activities of Daily Living (ADL) with LEFS
Time frame: 0, 2, 6, 12 weeks and 6 months post-surgery
Health Related Quality of Life with EQ-5D-5L
Time frame: 0, 2, 6, 12 weeks and 6 months post-surgery
Böhlers angle and posterior facet joint
Time frame: Early postoperative (before first mobilization) and 6 months post-surgery
Medical consumption with iMCQ
Time frame: 0 weeks and 6 months post-surgery
Society costs with iPCQ
Time frame: 0 weeks and 6 months post-surgery
Occurrence of complications
Time frame: 6 and 12 weeks and 6 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 39558368Verstappen C, Driessen MLS, Kalmet PHS, Brandts L, Kimman M, Edwards M, Hermans E, Poeze M. Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial. Trials. 2024 Nov 18;25(1):778. doi: 10.1186/s13063-024-08617-5.
- Individual participant dataSharing planned: No
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permissive Weight Bearing group and Restricted Weight Bearing group in people with Calcaneus Fracture and Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), run by Maastricht University Medical Center at 11 sites 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 5 inclusion and 14 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Coen Verstappen, MD (+31(0)43-3877489, coen.verstappen@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional outcome as defined by the AOFAS questionnaire (time frame: 0, 2, 6, 12 weeks and 6 months post-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 NCT05721378, 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 17 Oct 2024.