Autologous Fat in Peripheral Nerve Injury

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of autologous fat graft in enhancing peripheral nerve regeneration. The investigators hypothesize that fat grafting will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves.

Detailed Description
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Traumatic injuries to peripheral nerves are a frequent finding after hand trauma. High morbidity after nerve injuries mainly affects the younger and working population, with consequent decrease in life quality and productivity . Even in direct nerve repair and microsurgical nerve coaptation, regeneration is often suboptimal with incomplete target reinnervation. Suboptimal outcome is attributed to axonal degeneration, fibrotic scar formation, and neuromas at the site of injury. The use of adipose tissue has become very popular in tissue engineering and reconstructive surgery in recent years. It is proposed as a regenerative tool for various tissues, including peripheral nerves, because it offers an effective and minimally invasive procedure for obtaining stem cells. Unprocessed fat grafting can provide a simple approach to improve peripheral nerve regeneration by means of neoangiogenesis & inflammatory response modulation. Furthermore, it serves as a good protective barrier in peripheral nerve surgery, reducing fibrosis and adhesions. A recent study advocated by Tuncel et al, concluded that combined use of autologous fat graft with surgical repair methods induced significantly better regeneration in rats [3]. In another study by Kilic et al, using adipose tissue flap in a crush injury model in rats was found to be superior to other groups in myelin thickness, nerve fiber density, axon count, and functional recovery at 4 weeks. They concluded that fat tissue seems to promote nerve regeneration because of its stem cell content. To our knowledge, no prior studies have examined the use of fat graft in peripheral nerve repair in humans. So, the investigators proposed this clinical study to evaluate the outcomes of primary nerve repair combined with autologous fat graft in peripheral nerve injuries.

Official Title
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Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries

Conditions
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Nerve Injury

Intervention / Treatment
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* Procedure: Autologous Fat Grafting
* Procedure: Primary Nerve Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Acute median or ulnar nerve lacerations below elbow Exclusion Criteria: Old Nerve lacerations > 48 hours Nerve gap which requires nerve grafting Psychosocial issues that would limit participation and compliance

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (A): Primary nerve repair with autologous fat graft<br>Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope with autologous fat grafting around site of repair | Procedure: Autologous Fat Grafting<br>* The fat grafts will be harvested from the abdomen or lateral thighs in a closed sterile system, then prepared according to Coleman guidelines. The blood and oil layers are then separated from the adipose tissue. The lipoaspirate will be injected based on a technique described by Vaienti et al, by 17-gaug cannula which will be inserted through the skin around the main incision at the nerve repair site, and the fat graft will be injected after closure of the skin.<br>Procedure: Primary Nerve Repair<br>* Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.<br>|
| Active Comparator: Group (B): Standard primary nerve repair<br>Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting. | Procedure: Primary Nerve Repair<br>* Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified British Medical Research Council, sensory grading | standardized clinical assessment of sensory function using two-point discrimination and monofilament testing by a score from S0 to S4; the higher score indicates better sensation | 6-12 months | 
| Modified British Medical Research Council, motor grading | standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength. | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction study | measure for amplitude of response, latency of response and velocity of response measurements. | 6-12 months | 
| Disability of the Arm, Shoulder, and Hand (DASH) score | self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100 (most severe disability) | 6-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat graft, autologous fat, peripheral nerve injury