Fragility Fractures of the Pelvis (FFP)FFPNCT07636616
Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment for Fragility Fractures of the Pelvis Type 1-2 in Elderly Patients
A study testing Robot Assisted Minimally Invasive Fixation in people with Fragility Fractures of the Pelvis (FFP), run by Junbo Liang.
Trial summary
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fragility Fractures of the Pelvis (FFP)
- What is being tested?
- Robot Assisted Minimally Invasive Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Dec 2028
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years Low energy trauma Diagnosis of osteoporosis Diagnosis of FFP1 or FFP2 fragility fractures of the pelvis Injury duration less than 3 weeks Ability to walk independently or with assistance before injury Ability to provide written informed consent
Who cannot join
- Severe open injury or skin infection at the surgical site Long term bedridden status or severe disability Severe psychiatric disorders or dementia Severe obesity affecting imaging quality Severe systemic diseases preventing surgery Pathological fracture Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment in Elderly Patients With FFP1-2 Fragility Fractures of the Pelvis
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis. Eligible patients will be stratified according to FFP classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or standardized conservative treatment. Primary and secondary outcomes include pain relief, functional recovery, fracture progression, venous thromboembolism events, complications, and healthcare resource utilization. The study aims to provide evidence for optimizing treatment strategies in elderly patients with pelvic fragility fractures.
Read the detailed description
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis.
A total of 152 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conservative treatment group. Randomization will be stratified according to FFP classification (FFP1 or FFP2) using a computer generated randomization sequence.
Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP1 or FFP2 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare pain control, early weight bearing, functional recovery, fracture progression, venous thromboembolism events, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic fixation, while patients in the conservative treatment group will receive standardized nonoperative management including pain control, anticoagulation prophylaxis, rehabilitation, and osteoporosis treatment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture progression and healing, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, opioid consumption, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal treatment strategy for elderly patients with FFP1-2 pelvic fragility fractures.
- Conditions
- Fragility Fractures of the Pelvis (FFP)
- Being tested
- Robot Assisted Minimally Invasive Fixation
- Keywords
- Fragility Fracture, pelvis, Robot Assisted Surgery, Conservative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Minimally Invasive FixationProcedure or surgery
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Minimally Invasive Treatment Group | Experimental | Participants undergo robot assisted minimally invasive fixation for FFP1-2 fragility fractures of the pelvis. Receives: Procedure: Robot Assisted Minimally Invasive Fixation |
| Conservative Treatment Group | Active comparator | Participants receive standardized conservative treatment including pain management, rehabilitation, anticoagulation prophylaxis, and osteoporosis treatment. Receives: Procedure: Robot Assisted Minimally Invasive Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Pain
Visual Analog Scale (VAS) for pain. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain severity.
Measured: At day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Majeed Pelvic Function Score
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Secondary outcomes (8)
EuroQol 5-Dimension 3-Level Questionnaire
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Short Musculoskeletal Function Assessment (SMFA)
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Fracture Progression and Healing
Assessment of fracture healing, secondary displacement, and FFP classification progression using pelvic CT.
Measured: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
complication
Assessment of complication events during follow up.
Measured: From treatment initiation to 1 year follow up
Opioid Consumption
Assessment of cumulative opioid consumption during hospitalization
Measured: Days 0-3 after treatment
Serum C-Reactive Protein Level
Measured: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
D-Dimer Level
Measured: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Hemoglobin Level
Measured: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Fragility Fractures of the Pelvis (FFP)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junbo Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junbo Liang, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636616
- Sponsor's protocol ID
- K20260153
- Acronym
- FFP
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zong Y, Li J, Li Z, Wang W. Minimally invasive surgery and conservative treatment achieve similar clinical outcomes in patients with type II fragility fractures of the pelvis. J Orthop Surg Res. 2025 Feb 27;20(1):210. doi: 10.1186/s13018-025-05581-x.
PubMed 40016842Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008.
PubMed 20231569Banierink H, Ten Duis K, de Vries R, Wendt K, Heineman E, Reininga I, IJpma F. Pelvic ring injury in the elderly: Fragile patients with substantial mortality rates and long-term physical impairment. PLoS One. 2019 May 28;14(5):e0216809. doi: 10.1371/journal.pone.0216809. eCollection 2019.
PubMed 31136589Yamamoto N, Someko H, Nakashima Y, Nakao S, Kaneko T, Tsuge T. Mortality following fragility fractures of the pelvis: Systematic review and meta-analysis. Injury. 2025 Oct;56(10):112618. doi: 10.1016/j.injury.2025.112618. Epub 2025 Jul 21.
PubMed 40714375Nakayama Y, Suzuki T, Kurozumi T, Watanabe Y. Progression to Rommens type IIIa fragility fracture of the pelvis managed by delayed open reduction and interdigitating screw fixation: A case report. Trauma Case Rep. 2023 Jan 13;43:100773. doi: 10.1016/j.tcr.2023.100773. eCollection 2023 Feb.
PubMed 36691632Rommens PM, Arand C, Hopf JC, Mehling I, Dietz SO, Wagner D. Progress of instability in fragility fractures of the pelvis: An observational study. Injury. 2019 Nov;50(11):1966-1973. doi: 10.1016/j.injury.2019.08.038. Epub 2019 Aug 27.
PubMed 31492514Jiang Y, Qi X, Cui H, Huang Y, Lv Y, Yang Y, Yao X, Yang D. The Inflammation-Energy Metabolism Axis: A Central Driver of Sarcopenia-Osteoporosis: A Narrative Review. Calcif Tissue Int. 2026 Jan 7;117(1):9. doi: 10.1007/s00223-025-01473-8.
PubMed 41495343Lin YH, Shih YT, Teng MMH. The Impact of the "Osteo" Component of Osteosarcopenia on Fragility Fractures in Post-Menopausal Women. Int J Mol Sci. 2021 May 17;22(10):5256. doi: 10.3390/ijms22105256.
PubMed 34067582Meermans G, van Egmond JC. Malnutrition in Older Hip Fracture Patients: Prevalence, Pathophysiology, Clinical Outcomes, and Treatment-A Systematic Review. J Clin Med. 2025 Aug 11;14(16):5662. doi: 10.3390/jcm14165662.
PubMed 40869488Rommens PM, Arand C, Hofmann A, Wagner D. When and How to Operate Fragility Fractures of the Pelvis? Indian J Orthop. 2019 Jan-Feb;53(1):128-137. doi: 10.4103/ortho.IJOrtho_631_17.
PubMed 30905993Ali KA, He L, Li W, Zhang W, Huang H. Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study. BMC Geriatr. 2024 Apr 4;24(1):314. doi: 10.1186/s12877-024-04929-y.
PubMed 38575871Hutchings L, Roffey DM, Lefaivre KA. Fragility Fractures of the Pelvis: Current Practices and Future Directions. Curr Osteoporos Rep. 2022 Dec;20(6):469-477. doi: 10.1007/s11914-022-00760-9. Epub 2022 Nov 7.
PubMed 36342642GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
PubMed 34723233
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment in Elderly Patients With FFP1-2 Fragility Fractures of the Pelvis
- ClinicalTrials.gov ID
- NCT07636616
- Acronym / sponsor ID
- FFP / K20260153
- Conditions
- Fragility Fractures of the Pelvis (FFP)
- Keywords
- Fragility Fracture, pelvis, Robot Assisted Surgery, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Junbo LiangUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Jun 2026 (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 prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis. Eligible patients will be stratified according to FFP classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or standardized conservative treatment. Primary and secondary outcomes include pain relief, functional recovery, fracture progression, venous thromboembolism events, complications, and healthcare resource utilization. The study aims to provide evidence for optimizing treatment strategies in elderly patients with pelvic fragility fractures.
Detailed description
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis.
A total of 152 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conservative treatment group. Randomization will be stratified according to FFP classification (FFP1 or FFP2) using a computer generated randomization sequence.
Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP1 or FFP2 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare pain control, early weight bearing, functional recovery, fracture progression, venous thromboembolism events, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic fixation, while patients in the conservative treatment group will receive standardized nonoperative management including pain control, anticoagulation prophylaxis, rehabilitation, and osteoporosis treatment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture progression and healing, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, opioid consumption, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal treatment strategy for elderly patients with FFP1-2 pelvic fragility fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Minimally Invasive Treatment Group | Experimental | Procedure: Robot Assisted Minimally Invasive FixationParticipants undergo robot assisted minimally invasive fixation for FFP1-2 fragility fractures of the pelvis. |
| Conservative Treatment Group | Active comparator | Procedure: Robot Assisted Minimally Invasive FixationParticipants receive standardized conservative treatment including pain management, rehabilitation, anticoagulation prophylaxis, and osteoporosis treatment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 60 years Low energy trauma Diagnosis of osteoporosis Diagnosis of FFP1 or FFP2 fragility fractures of the pelvis Injury duration less than 3 weeks Ability to walk independently or with assistance before injury Ability to provide written informed consent
Key exclusion criteria (1 listed)
- Severe open injury or skin infection at the surgical site Long term bedridden status or severe disability Severe psychiatric disorders or dementia Severe obesity affecting imaging quality Severe systemic diseases preventing surgery Pathological fracture Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy
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 |
|---|---|---|
| Robot Assisted Minimally Invasive FixationRobot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures. | Procedure or surgery | Conservative Treatment Group, Robot Assisted Minimally Invasive Treatment Group |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: At day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Visual Analog Scale (VAS) for pain. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain severity.
Majeed Pelvic Function Score
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
8 secondary outcomes
EuroQol 5-Dimension 3-Level Questionnaire
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Short Musculoskeletal Function Assessment (SMFA)
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Fracture Progression and Healing
Time frame: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
complication
Time frame: From treatment initiation to 1 year follow up
Opioid Consumption
Time frame: Days 0-3 after treatment
Serum C-Reactive Protein Level
Time frame: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
D-Dimer Level
Time frame: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
Hemoglobin Level
Time frame: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
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 9 Jun 2026.
- Results publication: PubMed 40016842Zong Y, Li J, Li Z, Wang W. Minimally invasive surgery and conservative treatment achieve similar clinical outcomes in patients with type II fragility fractures of the pelvis. J Orthop Surg Res. 2025 Feb 27;20(1):210. doi: 10.1186/s13018-025-05581-x.
- Results publication: PubMed 20231569Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008.
- Results publication: PubMed 31136589Banierink H, Ten Duis K, de Vries R, Wendt K, Heineman E, Reininga I, IJpma F. Pelvic ring injury in the elderly: Fragile patients with substantial mortality rates and long-term physical impairment. PLoS One. 2019 May 28;14(5):e0216809. doi: 10.1371/journal.pone.0216809. eCollection 2019.
- Results publication: PubMed 40714375Yamamoto N, Someko H, Nakashima Y, Nakao S, Kaneko T, Tsuge T. Mortality following fragility fractures of the pelvis: Systematic review and meta-analysis. Injury. 2025 Oct;56(10):112618. doi: 10.1016/j.injury.2025.112618. Epub 2025 Jul 21.
- Results publication: PubMed 36691632Nakayama Y, Suzuki T, Kurozumi T, Watanabe Y. Progression to Rommens type IIIa fragility fracture of the pelvis managed by delayed open reduction and interdigitating screw fixation: A case report. Trauma Case Rep. 2023 Jan 13;43:100773. doi: 10.1016/j.tcr.2023.100773. eCollection 2023 Feb.
- Results publication: PubMed 31492514Rommens PM, Arand C, Hopf JC, Mehling I, Dietz SO, Wagner D. Progress of instability in fragility fractures of the pelvis: An observational study. Injury. 2019 Nov;50(11):1966-1973. doi: 10.1016/j.injury.2019.08.038. Epub 2019 Aug 27.
- Results publication: PubMed 41495343Jiang Y, Qi X, Cui H, Huang Y, Lv Y, Yang Y, Yao X, Yang D. The Inflammation-Energy Metabolism Axis: A Central Driver of Sarcopenia-Osteoporosis: A Narrative Review. Calcif Tissue Int. 2026 Jan 7;117(1):9. doi: 10.1007/s00223-025-01473-8.
- Results publication: PubMed 34067582Lin YH, Shih YT, Teng MMH. The Impact of the "Osteo" Component of Osteosarcopenia on Fragility Fractures in Post-Menopausal Women. Int J Mol Sci. 2021 May 17;22(10):5256. doi: 10.3390/ijms22105256.
- Results publication: PubMed 40869488Meermans G, van Egmond JC. Malnutrition in Older Hip Fracture Patients: Prevalence, Pathophysiology, Clinical Outcomes, and Treatment-A Systematic Review. J Clin Med. 2025 Aug 11;14(16):5662. doi: 10.3390/jcm14165662.
- Results publication: PubMed 30905993Rommens PM, Arand C, Hofmann A, Wagner D. When and How to Operate Fragility Fractures of the Pelvis? Indian J Orthop. 2019 Jan-Feb;53(1):128-137. doi: 10.4103/ortho.IJOrtho_631_17.
- Results publication: PubMed 38575871Ali KA, He L, Li W, Zhang W, Huang H. Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study. BMC Geriatr. 2024 Apr 4;24(1):314. doi: 10.1186/s12877-024-04929-y.
- Results publication: PubMed 36342642Hutchings L, Roffey DM, Lefaivre KA. Fragility Fractures of the Pelvis: Current Practices and Future Directions. Curr Osteoporos Rep. 2022 Dec;20(6):469-477. doi: 10.1007/s11914-022-00760-9. Epub 2022 Nov 7.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Assisted Minimally Invasive Fixation in people with Fragility Fractures of the Pelvis (FFP), run by Junbo Liang.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Junbo Liang (0576-85190463, liangjb@enzemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Pain (time frame: At day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment). The study lists 2 primary outcomes in all. 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 NCT07636616, which also lists 13 linked publications.
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 9 Jun 2026.