Autologous Fat in Peripheral Nerve Injury

Not Applicable

• Conditions: Nerve Injury
• Interventions: Procedure: Autologous Fat Grafting; Procedure: Primary Nerve Repair

• Registration Number: NCT04653129
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-07
• Study Start: 2021-01
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A): Primary nerve repair with autologous fat graft	Autologous Fat Grafting	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
Group (A): Primary nerve repair with autologous fat graft	Primary Nerve Repair	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
Group (B): Standard primary nerve repair	Primary Nerve Repair	Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.

Primary Outcome Measures

Name	Time	Method
Modified British Medical Research Council, sensory grading	6-12 months	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
Modified British Medical Research Council, motor grading	6-12 months	standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.

Secondary Outcome Measures

Name	Time	Method
Nerve conduction study	6-12 months	measure for amplitude of response, latency of response and velocity of response measurements.
Disability of the Arm, Shoulder, and Hand (DASH) score	6-12 months	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)