Clavicle FractureNCT06050473
Supraclavicular Nerve During Clavicle ORIF
A study testing Nerve-sacrificing procedure and Nerve preserving procedure in people with Clavicle Fracture, run by HealthPartners Institute.
Trial summary
Clavicle fractures are a common orthopedic injury and make up 2.6%-5% of all fractures. Despite the benefits of operative management, post-operative chest wall paresthesia is a well-known complication among surgeons and is well described in the literature. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Nerve-sacrificing procedure and Nerve preserving procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2016to 10 Aug 2023
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients >17 years old with a displaced, midshaft clavicle fracture
- Closed injury
- No skin compromise
Who cannot join
- Clavicle non-union/malunion
- Far proximal (medial) or far distal (lateral) clavicle fractures
- Open injury
- Skin compromise
- Prior surgery of the anterior chest wall or affected clavicle
- Pre-existing chest wall numbness, cervical root symptoms, neurologic or sensory deficits, signs of neuropathy
Show all 9Show fewer
- We will not exclude patients on membrane stabilizing medications for nerve paresthesia (GABA agonists, tricyclic anti-depressants) but will include this on patient intake form and document it
- Traumatic brain injury
- Patients who had prior deltopectoral approach to glenoid
About this study
Official title: Preservation vs Sacrifice of the Supraclavicular Nerve During Clavicle ORIF: A Randomized Controlled Trial
Clavicle fractures are a common orthopedic injury and make up 2.6%-5% of all fractures. Despite the benefits of operative management, post-operative chest wall paresthesia is a well-known complication among surgeons and is well described in the literature. Studies reporting on the natural history of post-operative paresthesia report an incidence of chest wall numbness anywhere from 10-80% and this is attributed to iatrogenic injury of the branches of the supraclavicular nerve that provide sensation over the clavicle, anteromedial shoulder and proximal chest. While this may seem like an easy complication to avoid, anatomic studies give insight into the complex and unpredictable branching of the supraclavicular nerve. The aim of this study was to compare the area (cm2) and change in size over time of post-operative paresthesia (includes hypesthesia and dysesthesia) following ORIF of displaced clavicle fractures between nerve-sacrificing and nerve-preserving procedures.
Read the detailed description
This is a prospective, partially-blinded, single center, randomized controlled trial to compare the post-operative outcomes of paresthesias and morbidity between nerve-preserving and nerve-sacrificing procedures after surgical fixation of clavicle fractures. Although prior studies explore different incision orientation, most fail to specify whether or not the supraclavicular nerve branches were identified and protected and also lack a patient questionnaire that focuses on paresthesia characteristics and patient quality of life as it relates to the measured area of postoperative numbness. In this proposed study, the investigators will be able to fill this gap in knowledge and give insight into whether or not a nerve-sparing technique should be used to decrease the morbidity of postoperative chest wall paresthesia following operative fixation of clavicle fractures. This research will be important to the scientific community because it will help guide a physician's pre-operative counseling and establish realistic expectations for their patients. It could also guide a physician's surgical technique in a manner to decrease post-operative morbidity for patient's undergoing surgical fixation of clavicle fractures.
- Group 1 - Operative treatment utilizing a supraclavicular nerve-sacrificing procedure
- Group 2 - Operative treatment utilizing a supraclavicular nerve-preserving procedure
- Conditions
- Clavicle Fracture
- Being tested
- Nerve-sacrificing procedure, Nerve preserving procedure
- Keywords
- Clavicle, Fracture, Supraclavicular nerve, Post-operative, Paresthesia
- Medical subject headings
- Fractures, Bone, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve-sacrificing procedureProcedure or surgery
Surgical fixation of the clavicle fracture will be performed through a horizontal incision over the clavicle. During the incision and soft tissue dissection, the surgeon will not attempt to identify the supraclavicular nerve branches. Instead, the surgeon will cut the nerve branches during the dissection.
Nerve preserving procedureProcedure or surgery
Surgical fixation of the clavicle fracture will be performed through the same horizontal incision over the clavicle. The surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular nerve-sacrificing procedure | Active comparator | Surgeon will not attempt to identify the supraclavicular nerve branches. Receives: Procedure: Nerve-sacrificing procedure |
| Supraclavicular nerve-preserving procedure | Active comparator | Surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure. Receives: Procedure: Nerve preserving procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paresthesia mapping
A trained research fellow will be blinded to the operative intervention performed and will measure the area of chest wall paresthesia using a transparency grid made up of 1cmx1cm squares. The transparency grid will be placed over the patient's clavicle and the patient will be instructed to palpate the chest wall for areas of paresthesia. The examiner will then outline the area of paresthesia by tracing it onto the transparency slide.
Measured: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Secondary outcomes (3)
Cutaneous Hyperesthesia/dysesthesia mapping
A 10 gram Semmes-Weinstein monofilament will be applied twice, for 1 second at each point as indicated on the diagram in Appendix E. It will be applied to two points at the medial 1/3, middle 1/3 and lateral 1/3 of the subclavicular region, 3cm distal the inferior border of the clavicle at each point. The monofilament will be applied twice for 1 second at each point. Unperceived points will be identified and recorded based on location at medial, middle or lateral 1/3. If this monofilament test results in dysesthesia (pain, tingling, shock like sensations), this will be recorded similarly.
Measured: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Patient Morbidity
The research fellow will administer the Patient Morbidity questionnaire and record the patient's responses. This outlines the characteristics of the paresthesia and the effect on the patient. This will be the investigator's measure of patient-reported morbidity.
Measured: Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Disabilities of the Arm, Shoulder and Hand (DASH); A 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).
The patient will fill out the Disability of Arm, Shoulder \& Hand questionnaire as a measure of functional outcome.
Measured: Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start2 Nov 2016
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter A Cole, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050473
- Sponsor's protocol ID
- A16-535
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg. 2007 Apr;15(4):239-48. doi: 10.5435/00124635-200704000-00007.
PubMed 17426295Christensen TJ, Horwitz DS, Kubiak EN. Natural history of anterior chest wall numbness after plating of clavicle fractures: educating patients. J Orthop Trauma. 2014 Nov;28(11):642-7. doi: 10.1097/BOT.0000000000000095.
PubMed 24662990Ahrens PM, Garlick NI, Barber J, Tims EM; Clavicle Trial Collaborative Group. The Clavicle Trial: A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures. J Bone Joint Surg Am. 2017 Aug 16;99(16):1345-1354. doi: 10.2106/JBJS.16.01112.
PubMed 28816894Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.
PubMed 17200303Robinson CM, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, Foster CJ, Clark K, Brooksbank AJ, Arthur A, Crowther MA, Packham I, Chesser TJ. Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg Am. 2013 Sep 4;95(17):1576-84. doi: 10.2106/JBJS.L.00307.
PubMed 24005198Ahmed AF, Salameh M, AlKhatib N, Elmhiregh A, Ahmed GO. Open Reduction and Internal Fixation Versus Nonsurgical Treatment in Displaced Midshaft Clavicle Fractures: A Meta-Analysis. J Orthop Trauma. 2018 Jul;32(7):e276-e283. doi: 10.1097/BOT.0000000000001174.
PubMed 29672340Nathe T, Tseng S, Yoo B. The anatomy of the supraclavicular nerve during surgical approach to the clavicular shaft. Clin Orthop Relat Res. 2011 Mar;469(3):890-4. doi: 10.1007/s11999-010-1608-x. Epub 2010 Oct 9.
PubMed 20936387Lemieux V, Afsharpour S, Nam D, Elmaraghy A. Incisional paresthesia following clavicle plate fixation: does it matter to patients? BMC Musculoskelet Disord. 2021 Nov 3;22(1):928. doi: 10.1186/s12891-021-04770-z.
PubMed 34732198Havet E, Duparc F, Tobenas-Dujardin AC, Muller JM, Freger P. Morphometric study of the shoulder and subclavicular innervation by the intermediate and lateral branches of supraclavicular nerves. Surg Radiol Anat. 2007 Dec;29(8):605-10. doi: 10.1007/s00276-007-0258-5. Epub 2007 Sep 13.
PubMed 17851634Jelev L, Surchev L. Study of variant anatomical structures (bony canals, fibrous bands, and muscles) in relation to potential supraclavicular nerve entrapment. Clin Anat. 2007 Apr;20(3):278-85. doi: 10.1002/ca.20368.
PubMed 16838268Wang K, Dowrick A, Choi J, Rahim R, Edwards E. Post-operative numbness and patient satisfaction following plate fixation of clavicular fractures. Injury. 2010 Oct;41(10):1002-5. doi: 10.1016/j.injury.2010.02.028. Epub 2010 Mar 12.
PubMed 20219192Erdogan M, Desteli EE, Imren Y, Kilic M, Ulusoy S, Varli A. Supraclavicular neuropathy after surgical treatment of clavicular fractures: comparison of two incisions. Acta Chir Orthop Traumatol Cech. 2014;81(6):387-91.
PubMed 25651293Chechik O, Batash R, Goldstein Y, Snir N, Amar E, Drexler M, Maman E, Dolkart O. Surgical approach for open reduction and internal fixation of clavicle fractures: a comparison of vertical and horizontal incisions. Int Orthop. 2019 Aug;43(8):1977-1982. doi: 10.1007/s00264-018-4139-9. Epub 2018 Sep 5.
PubMed 30187099Beirer M, Postl L, Cronlein M, Siebenlist S, Huber-Wagner S, Braun KF, Biberthaler P, Kirchhoff C. Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures? BMC Musculoskelet Disord. 2015 May 28;16:128. doi: 10.1186/s12891-015-0592-4.
PubMed 26018526Ko SH, Kim MS. Comparison of supraclavicular nerve injuries after clavicle mid-shaft surgery via minimally invasive plate osteosynthesis versus open reduction and internal fixation. Arch Orthop Trauma Surg. 2022 Aug;142(8):1895-1902. doi: 10.1007/s00402-021-03941-w. Epub 2021 May 9.
PubMed 33966101
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation vs Sacrifice of the Supraclavicular Nerve During Clavicle ORIF: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06050473
- Acronym / sponsor ID
- A16-535
- Conditions
- Clavicle Fracture
- Keywords
- Clavicle, Fracture, Supraclavicular nerve, Post-operative, Paresthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 22 Sep 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.
Clavicle fractures are a common orthopedic injury and make up 2.6%-5% of all fractures. Despite the benefits of operative management, post-operative chest wall paresthesia is a well-known complication among surgeons and is well described in the literature. Studies reporting on the natural history of post-operative paresthesia report an incidence of chest wall numbness anywhere from 10-80% and this is attributed to iatrogenic injury of the branches of the supraclavicular nerve that provide sensation over the clavicle, anteromedial shoulder and proximal chest. While this may seem like an easy complication to avoid, anatomic studies give insight into the complex and unpredictable branching of the supraclavicular nerve. The aim of this study was to compare the area (cm2) and change in size over time of post-operative paresthesia (includes hypesthesia and dysesthesia) following ORIF of displaced clavicle fractures between nerve-sacrificing and nerve-preserving procedures.
Detailed description
This is a prospective, partially-blinded, single center, randomized controlled trial to compare the post-operative outcomes of paresthesias and morbidity between nerve-preserving and nerve-sacrificing procedures after surgical fixation of clavicle fractures. Although prior studies explore different incision orientation, most fail to specify whether or not the supraclavicular nerve branches were identified and protected and also lack a patient questionnaire that focuses on paresthesia characteristics and patient quality of life as it relates to the measured area of postoperative numbness. In this proposed study, the investigators will be able to fill this gap in knowledge and give insight into whether or not a nerve-sparing technique should be used to decrease the morbidity of postoperative chest wall paresthesia following operative fixation of clavicle fractures. This research will be important to the scientific community because it will help guide a physician's pre-operative counseling and establish realistic expectations for their patients. It could also guide a physician's surgical technique in a manner to decrease post-operative morbidity for patient's undergoing surgical fixation of clavicle fractures.
- Group 1 - Operative treatment utilizing a supraclavicular nerve-sacrificing procedure
- Group 2 - Operative treatment utilizing a supraclavicular nerve-preserving procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular nerve-sacrificing procedure | Active comparator | Procedure: Nerve-sacrificing procedureSurgeon will not attempt to identify the supraclavicular nerve branches. |
| Supraclavicular nerve-preserving procedure | Active comparator | Procedure: Nerve preserving procedureSurgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >17 years old with a displaced, midshaft clavicle fracture
- Closed injury
- No skin compromise
Key exclusion criteria (9 listed)
- Clavicle non-union/malunion
- Far proximal (medial) or far distal (lateral) clavicle fractures
- Open injury
- Skin compromise
- Prior surgery of the anterior chest wall or affected clavicle
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 |
|---|---|---|
| Nerve-sacrificing procedureSurgical fixation of the clavicle fracture will be performed through a horizontal incision over the clavicle. During the incision and soft tissue dissection, the surgeon will not attempt to identify the supraclavicular nerve branches. Instead, the surgeon will cut the nerve branches during the dissection. | Procedure or surgery | Supraclavicular nerve-sacrificing procedure |
| Nerve preserving procedureSurgical fixation of the clavicle fracture will be performed through the same horizontal incision over the clavicle. The surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure. | Procedure or surgery | Supraclavicular nerve-preserving procedure |
Primary outcome
Paresthesia mapping
Time frame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
A trained research fellow will be blinded to the operative intervention performed and will measure the area of chest wall paresthesia using a transparency grid made up of 1cmx1cm squares. The transparency grid will be placed over the patient's clavicle and the patient will be instructed to palpate the chest wall for areas of paresthesia. The examiner will then outline the area of paresthesia by tracing it onto the transparency slide.
3 secondary outcomes
Cutaneous Hyperesthesia/dysesthesia mapping
Time frame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Patient Morbidity
Time frame: Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Disabilities of the Arm, Shoulder and Hand (DASH); A 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).
Time frame: Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 17426295Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg. 2007 Apr;15(4):239-48. doi: 10.5435/00124635-200704000-00007.
- Background: PubMed 24662990Christensen TJ, Horwitz DS, Kubiak EN. Natural history of anterior chest wall numbness after plating of clavicle fractures: educating patients. J Orthop Trauma. 2014 Nov;28(11):642-7. doi: 10.1097/BOT.0000000000000095.
- Background: PubMed 28816894Ahrens PM, Garlick NI, Barber J, Tims EM; Clavicle Trial Collaborative Group. The Clavicle Trial: A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures. J Bone Joint Surg Am. 2017 Aug 16;99(16):1345-1354. doi: 10.2106/JBJS.16.01112.
- Background: PubMed 17200303Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.
- Background: PubMed 24005198Robinson CM, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, Foster CJ, Clark K, Brooksbank AJ, Arthur A, Crowther MA, Packham I, Chesser TJ. Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg Am. 2013 Sep 4;95(17):1576-84. doi: 10.2106/JBJS.L.00307.
- Background: PubMed 29672340Ahmed AF, Salameh M, AlKhatib N, Elmhiregh A, Ahmed GO. Open Reduction and Internal Fixation Versus Nonsurgical Treatment in Displaced Midshaft Clavicle Fractures: A Meta-Analysis. J Orthop Trauma. 2018 Jul;32(7):e276-e283. doi: 10.1097/BOT.0000000000001174.
- Background: PubMed 20936387Nathe T, Tseng S, Yoo B. The anatomy of the supraclavicular nerve during surgical approach to the clavicular shaft. Clin Orthop Relat Res. 2011 Mar;469(3):890-4. doi: 10.1007/s11999-010-1608-x. Epub 2010 Oct 9.
- Background: PubMed 34732198Lemieux V, Afsharpour S, Nam D, Elmaraghy A. Incisional paresthesia following clavicle plate fixation: does it matter to patients? BMC Musculoskelet Disord. 2021 Nov 3;22(1):928. doi: 10.1186/s12891-021-04770-z.
- Background: PubMed 17851634Havet E, Duparc F, Tobenas-Dujardin AC, Muller JM, Freger P. Morphometric study of the shoulder and subclavicular innervation by the intermediate and lateral branches of supraclavicular nerves. Surg Radiol Anat. 2007 Dec;29(8):605-10. doi: 10.1007/s00276-007-0258-5. Epub 2007 Sep 13.
- Background: PubMed 16838268Jelev L, Surchev L. Study of variant anatomical structures (bony canals, fibrous bands, and muscles) in relation to potential supraclavicular nerve entrapment. Clin Anat. 2007 Apr;20(3):278-85. doi: 10.1002/ca.20368.
- Background: PubMed 20219192Wang K, Dowrick A, Choi J, Rahim R, Edwards E. Post-operative numbness and patient satisfaction following plate fixation of clavicular fractures. Injury. 2010 Oct;41(10):1002-5. doi: 10.1016/j.injury.2010.02.028. Epub 2010 Mar 12.
- Background: PubMed 25651293Erdogan M, Desteli EE, Imren Y, Kilic M, Ulusoy S, Varli A. Supraclavicular neuropathy after surgical treatment of clavicular fractures: comparison of two incisions. Acta Chir Orthop Traumatol Cech. 2014;81(6):387-91.
- 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.
Peter A Cole, MD principal investigator
HealthPartners Institute
Questions about this trial
What is this clinical trial studying?
A study testing Nerve-sacrificing procedure and Nerve preserving procedure in people with Clavicle Fracture, run by HealthPartners Institute.
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 3 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: finished, as of the sponsor's last update on 22 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paresthesia mapping (time frame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative). 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 NCT06050473, which also lists 25 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 22 Sep 2023.