Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 44
- Primary Endpoint
- Modified British Medical Research Council, sensory grading
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
the assessment of outcome measures will be performed by a dedicated surgeon not involved in the surgery or preoperative patient evaluation
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Modified British Medical Research Council, sensory grading
Time Frame: 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
Time Frame: 6-12 months
standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.
Secondary Outcomes
- Nerve conduction study(6-12 months)
- Disability of the Arm, Shoulder, and Hand (DASH) score(6-12 months)
Investigators
Ahmed ElSayed Sharaf Ahmed
Assistant Lecturer
Assiut University