Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome

NCT03722303 | Suspended Early Phase 1 FDA Drug

• 1 other identifier: AAAK4700
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal; tunnel; injection; steroid; lipografting; numbness; tingling; median nerve

Outcome Measures

Primary Outcomes (1)

• Functional Outcome Score

  This score will be determined by Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH), which is a validated tool/survey for measuring upper extremity disability. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). These raw scores are used to calculate a score out of 100, with a higher score indicating greater disability.

  Up to 1 year post-treatment

Secondary Outcomes (2)

• Score on the Michigan Hand Questionnaire (MHQ)

  Up to 1 year post-treatment

• Score on the Brigham Women's Carpal Tunnel Questionnaire

  Up to 1 year post-treatment

Study Arms (2)

Steroid Injection

ACTIVE COMPARATOR

Subjects with CTS will receive steroid injection.

Drug: Steroid Injection

Fat Injection

EXPERIMENTAL

Subjects with CTS will receive fat injection.

Other: Fat Injection

Interventions

Fat Injection OTHER

Used by plastic surgeons, lipografting injects autologous fat to correct contour deformities. Plastic surgeons have witnessed the regenerative properties of fat transfer, and these clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions. This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors stimulate nerve regeneration.

Also known as: Fat Transfer

Fat Injection

Steroid Injection DRUG

Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome

Also known as: Cortisone Injection

Steroid Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary mild to moderate carpal tunnel syndrome (CTS)
• report symptoms longer than 6 months
• night pain
• weakness
• sensory deficits
• fluent English-speaking adult (\>18)

You may not qualify if:

• \<18 years old
• Non-english speaking
• injection in past 6 months
• previous hand surgery
• previous hand trauma (fracture or dislocation)

Sponsors & Collaborators

• Columbia University: lead
• Orthopaedic Scientific Research Foundation: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (4)

• LeBlanc KE, Cestia W. Carpal tunnel syndrome. Am Fam Physician. 2011 Apr 15;83(8):952-8.

  PMID: 21524035 BACKGROUND

• Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.

  PMID: 17443508 BACKGROUND

• Gutowski KA; ASPS Fat Graft Task Force. Current applications and safety of autologous fat grafts: a report of the ASPS fat graft task force. Plast Reconstr Surg. 2009 Jul;124(1):272-280. doi: 10.1097/PRS.0b013e3181a09506.

  PMID: 19346997 BACKGROUND

• Ibrahim I, Khan WS, Goddard N, Smitham P. Carpal tunnel syndrome: a review of the recent literature. Open Orthop J. 2012;6:69-76. doi: 10.2174/1874325001206010069. Epub 2012 Feb 23.

  PMID: 22470412 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Hypesthesia; Paresthesia

Interventions

CD36 Antigens; Steroids; Cortisone

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein; Fused-Ring Compounds; Polycyclic Compounds; Pregnenes; Pregnanes; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Melvin P Rosenwasser, MD

  Department of Orthopaedic Surgery at Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: December 19, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)