Leg Length InequalityFitForFranceNCT06156384
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
An observational study of Leg Length Inequality, run by Orthofix s.r.l. at 6 sites in 2 countries.
Trial summary
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs. The following parameters will be assessed for up to 24 months. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leg Length Inequality
- What is being tested?
- FITBONE® Lengthening Nail
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 45 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Jun 2024to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The aim of the study is to have a representative population of FITBONE patients in France, who are cimpliant with the inclusion criteria, during the 1 year enrollment period. Any centre in France that uses FITBONE in their routine clinical practice will be invited and have the opportunity to participate in this study. All centres must systematically and without exception offer every patient being implanted with FITBONE the opportunity to participate in the study, limiting selection bias and increasing the representativeness of this study to the French population.
Who may be able to join
- Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE
- Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU
- The patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)
- The informed consent form is correctly obtained
Who cannot join
- Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.
- Patients with any conditions that, in the Investigator's opinion, may interfere with the study execution, including those likely to be lost to follow-up.
- Patients who have any conditions or medical condition that, in the investigator's opinion, may interfere with the study's execution or in which the patient should not participate for safety reasons.
- Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).
- Patients participating in other clinical or have taken part in any clinical study in the last 3 months.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
France5 sites, 5 recruiting
- Recruiting
CHU Lille - Hôpital Jeanne de Flandre
Lille, Hauts-de-France, 59120
Damien Fron, MD
Damien Fron, MD
- Recruiting
Hôpital Sainte-Marguerite AP-HM
Marseille, Provence-Alpes-Côte d'Azur Region, 13274
Maxime Fabre-Aubrespy, MD
Maxime Fabre-Aubrespy, MD
- Recruiting
CHU de Saint-Étienne Hôpital Nord
Saint-Etienne, Auvergne-Rhône-Alpes, 42270
Hassan Al Khoury Salem, MD
Hassan Al Khoury Salem, MD
- Recruiting
CHU de Strasbourg
Strasbourg, Grand Est, 67091
Ludovic Paul Schneider, MD
Ludovic Paul Schneider, MD
- Recruiting
Centre hospitalier universitaire (CHU) de Toulouse
Toulouse, Occitanie, 31300
Franck Accadbled, Prof.
Franck Accadbled, Prof.
Reunion1 site, 1 recruiting
- Recruiting
CHU de La Réunion site Sud Saint-Pierre
Saint-Pierre, La Réunion, 97448
Jean Christophe Ruzic, MD
Jean Christophe Ruzic, MD
About this study
Official title: Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.
The following parameters will be assessed for up to 24 months.
- Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA)
- Patient satisfaction using the Patient Global Impression of change (PGI-C) scale
- QoL using the 36-Item Short Form Survey/Paediatric Quality of Life Inventory (SF-36/PedsQL)
Read the detailed description
The study period is 24 months post-surgery. Each patient's demographic data, medical history, any relevant concomitant medication, physical examination, range of motion data will be recorded using a standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patient's conditions and record determination as to whether FITBONE is recommended. The decision to treat, observe, and to include in this observation study is at the discretion of the healthcare provider. This is an observational study and therefore, the participating healthcare provider will manage patients according to the usual clinical practice.
Surgery will be performed according to the standard surgical procedure described previously. Study of Investigational Product(s). Five to ten days after the lengthening nail placement, the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside. This period is referred to as the distraction period. The rhythm of lengthening and strict protocol for an individual patient, indicating the daily lengths of lengthening to be applied, are decided by the healthcare provider taking into account all influencing factors. Therefore, the end of the distraction period, bone healing, implant removal, and 6 months post-implant removal may differ by individual. In the event the distraction period is extended by the healthcare provider, the new distraction period will determine the end of the distraction time point. All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions.
Six visits are planned:
- Surgery (baseline)
- End of the distraction phase
- End of bone healing
- Implant removal
- 6-month post-removal
- 24-month post-surgery The satisfaction will be assessed at implant removal, 6 months post implant removal, and 24 months post-surgery.
The QoL will be assessed at baseline, at 6 months post implant removal, and 24 months post-surgery.
Pain will be assessed at all timepoints. Measurement of pain at the end of the distraction phase, the patient will be requested to report the pain experienced in the past week, at the moment, and during or immediately after the distraction period. At other time points, pain for only at the moment will be captured.
Range of motion (ROM) will be measured at the end of bone healing, and at the 24 months post-surgery.
Lengthening achieved will be measured at the end of bone healing. Any incidence of adverse events will be recorded at any point during the 24-month follow-up period.
- Conditions
- Leg Length Inequality
- Being tested
- FITBONE® Lengthening Nail
- Keywords
- Fitbone, LLD, Bone lengthening, Nail, Nailing, Intramedullary nailing, Intramedullary nail, Motorized Nail
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITBONE® Lengthening NailDevice
The patient is installed on a standard orthopaedic table, intramedullary reaming is performed through a metal working tube. The osteotomy is performed percutaneously and then an osteotome according to the postage-stamp technique. Once the FITBONE lengthening nail is placed in the desired location, it should be connected to the subcutaneous receiver. The receiver should be placed close enough to the skin surface to ensure the energy transfer from the external transmitter.
After 5 to 10 days after surgery, the lengthening mechanism is operated by the patient, using the transmitter. An elongation of approximately 1 mm/day takes place. The attending physician determines the rhythm of lengthening in each case. When the desired elongation length is reached, the consolidation phase begins, which is necessary for bone regeneration. The FITBONE lengthening nail can be removed once the bone has consolidated, approximately one to one and a half years after implantation.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients aged ≥12 years with congenital or acquired lower limb discrepancy, greater than 30mm Receives: Device: FITBONE® Lengthening Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe Patients' Pain by Visual Analog Scale (VAS)
Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.
Measured: at 6 months after implant removal date and at 24 months follow-up
Describe Patients' patient Quality of Life (QoL) using Short Form 36 Health Survey (SF-36) for adult patients and PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale for children patients.
The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.
Measured: at 6 months after implant removal date and at 24 months follow-up
Describe Patients' satisfaction
A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing Very much improved; to 7 being Very much worse.
Measured: at 6 months after implant removal date and at 24 months follow-up
Secondary outcomes (6)
Monitor the clinical safety of Fitbone by collecting and characterizing the complications, expressed as adverse events and device deficiencies, associated with FITBONE
The clinical safety of Fitbone will be measured Collecting and characterizing the complications (expressed as adverse events and device deficiencies) associated with FITBONE that will be assessed by the investigators.
Measured: from surgery to 24 months follow-up
Effectiveness of Fitbone by limb lengthening
The lengthening goal is considered 'achieved' when, at the end of bone healing, the limb length is within 5 mm of the lengthening objective defined by the investigator when using FITBONE.
Measured: at the end of bone healing, approximately 6 months
Assess satisfaction evolution at implant removal , 6 months after Fitbone removal and at 24 months after surgery
A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing "Very much improved" to 7 being "Very much worse".
Measured: from surgery to 24 months follow-up
Describe evolution of QoL at 6 months after Fitbone removal and at 24 months after surgery, compared to baseline
The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.
Measured: from surgery to 24 months follow-up
Describe pain at each visit using VAS
Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.
Measured: from surgery to 24 months follow-up
Describe patients Range Of Motion (ROM in degrees) evolution at end of bone healing and at 24 months after surgery compared to baseline
The knee range of motion will measured in degree Difference in the range of motion through the passive extension before surgery (baseline) to the end of bone healing, and at 24 months post-surgery
Measured: from surgery to 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start18 Jun 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length InequalityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franck Accadbled, Prof., Principal investigator, Centre hospitalier universitaire (CHU) de ToulouseMaxime Fabre-Aubrespy, MD, Principal investigator, Hôpital Sainte-Marguerite AP-HMDamien Fron, MD, Principal investigator, CHU LilleJean-Christophe Ruzic, MD, Principal investigator, CHU de La Réunion site Sud Saint-PierreHassan Al Khoury Salem, MD, Principal investigator, CHU de Saint-Étienne Hôpital NordLudovic Paul Schneider, MD, Principal investigator, CHU de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156384
- Sponsor's protocol ID
- OCI_2301
- Other IDs
- 2023-A02702-43
- Acronym
- FitForFrance
- Status last verified
- Aug 2025
- First submitted
- 22 Nov 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail
- ClinicalTrials.gov ID
- NCT06156384
- Acronym / sponsor ID
- FitForFrance / OCI_2301
- Conditions
- Leg Length Inequality
- Keywords
- Fitbone, LLD, Bone lengthening, Nail, Nailing, Intramedullary nailing, Intramedullary nail, Motorized Nail
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 5 Dec 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.
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.
The following parameters will be assessed for up to 24 months.
- Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA)
- Patient satisfaction using the Patient Global Impression of change (PGI-C) scale
- QoL using the 36-Item Short Form Survey/Paediatric Quality of Life Inventory (SF-36/PedsQL)
Detailed description
The study period is 24 months post-surgery. Each patient's demographic data, medical history, any relevant concomitant medication, physical examination, range of motion data will be recorded using a standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patient's conditions and record determination as to whether FITBONE is recommended. The decision to treat, observe, and to include in this observation study is at the discretion of the healthcare provider. This is an observational study and therefore, the participating healthcare provider will manage patients according to the usual clinical practice.
Surgery will be performed according to the standard surgical procedure described previously. Study of Investigational Product(s). Five to ten days after the lengthening nail placement, the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside. This period is referred to as the distraction period. The rhythm of lengthening and strict protocol for an individual patient, indicating the daily lengths of lengthening to be applied, are decided by the healthcare provider taking into account all influencing factors. Therefore, the end of the distraction period, bone healing, implant removal, and 6 months post-implant removal may differ by individual. In the event the distraction period is extended by the healthcare provider, the new distraction period will determine the end of the distraction time point. All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions.
Six visits are planned:
- Surgery (baseline)
- End of the distraction phase
- End of bone healing
- Implant removal
- 6-month post-removal
- 24-month post-surgery The satisfaction will be assessed at implant removal, 6 months post implant removal, and 24 months post-surgery.
The QoL will be assessed at baseline, at 6 months post implant removal, and 24 months post-surgery.
Pain will be assessed at all timepoints. Measurement of pain at the end of the distraction phase, the patient will be requested to report the pain experienced in the past week, at the moment, and during or immediately after the distraction period. At other time points, pain for only at the moment will be captured.
Range of motion (ROM) will be measured at the end of bone healing, and at the 24 months post-surgery.
Lengthening achieved will be measured at the end of bone healing. Any incidence of adverse events will be recorded at any point during the 24-month follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: FITBONE® Lengthening NailPatients aged ≥12 years with congenital or acquired lower limb discrepancy, greater than 30mm |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The aim of the study is to have a representative population of FITBONE patients in France, who are cimpliant with the inclusion criteria, during the 1 year enrollment period. Any centre in France that uses FITBONE in their routine clinical practice will be invited and have the opportunity to participate in this study. All centres must systematically and without exception offer every patient being implanted with FITBONE the opportunity to participate in the study, limiting selection bias and increasing the representativeness of this study to the French population.
Key inclusion criteria (4 listed)
- Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE
- Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU
- The patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)
- The informed consent form is correctly obtained
Key exclusion criteria (5 listed)
- Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.
- Patients with any conditions that, in the Investigator's opinion, may interfere with the study execution, including those likely to be lost to follow-up.
- Patients who have any conditions or medical condition that, in the investigator's opinion, may interfere with the study's execution or in which the patient should not participate for safety reasons.
- Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).
- Patients participating in other clinical or have taken part in any clinical study in the last 3 months.
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 |
|---|---|---|
| FITBONE® Lengthening NailThe patient is installed on a standard orthopaedic table, intramedullary reaming is performed through a metal working tube. The osteotomy is performed percutaneously and then an osteotome according to the postage-stamp technique. Once the FITBONE lengthening nail is placed in the desired location, it should be connected to the subcutaneous receiver. The receiver should be placed close enough to the skin surface to ensure the energy transfer from the external transmitter. After 5 to 10 days after surgery, the lengthening mechanism is operated by the patient, using the transmitter. An elongation of approximately 1 mm/day takes place. The attending physician determines the rhythm of lengthening in each case. When the desired elongation length is reached, the consolidation phase begins, which is necessary for bone regeneration. The FITBONE lengthening nail can be removed once the bone has consolidated, approximately one to one and a half years after implantation. | Device | Patients |
Primary outcome
Describe Patients' Pain by Visual Analog Scale (VAS)
Time frame: at 6 months after implant removal date and at 24 months follow-up
Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.
Describe Patients' patient Quality of Life (QoL) using Short Form 36 Health Survey (SF-36) for adult patients and PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale for children patients.
Time frame: at 6 months after implant removal date and at 24 months follow-up
The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.
Describe Patients' satisfaction
Time frame: at 6 months after implant removal date and at 24 months follow-up
A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing Very much improved; to 7 being Very much worse.
6 secondary outcomes
Monitor the clinical safety of Fitbone by collecting and characterizing the complications, expressed as adverse events and device deficiencies, associated with FITBONE
Time frame: from surgery to 24 months follow-up
Effectiveness of Fitbone by limb lengthening
Time frame: at the end of bone healing, approximately 6 months
Assess satisfaction evolution at implant removal , 6 months after Fitbone removal and at 24 months after surgery
Time frame: from surgery to 24 months follow-up
Describe evolution of QoL at 6 months after Fitbone removal and at 24 months after surgery, compared to baseline
Time frame: from surgery to 24 months follow-up
Describe pain at each visit using VAS
Time frame: from surgery to 24 months follow-up
Describe patients Range Of Motion (ROM in degrees) evolution at end of bone healing and at 24 months after surgery compared to baseline
Time frame: from surgery to 24 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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.
Franck Accadbled, Prof. principal investigator
Centre hospitalier universitaire (CHU) de Toulouse
Maxime Fabre-Aubrespy, MD principal investigator
Hôpital Sainte-Marguerite AP-HM
Damien Fron, MD principal investigator
CHU Lille
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Length Inequality, run by Orthofix s.r.l. at 6 sites in 2 countries.
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 5 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Reunion. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Marano (+39 0456719000, tommasomarano@orthofix.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe Patients' Pain by Visual Analog Scale (VAS) (time frame: at 6 months after implant removal date and at 24 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.