Autologous Fat in Peripheral Nerve Injury
Primary Purpose
Nerve Injury
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autologous Fat Grafting
Primary Nerve Repair
Sponsored by
About this trial
This is an interventional treatment trial for Nerve Injury focused on measuring fat graft, autologous fat, peripheral nerve injury
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group (A): Primary nerve repair with autologous fat graft
Group (B): Standard primary nerve repair
Arm Description
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
Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Nerve conduction study
measure for amplitude of response, latency of response and velocity of response measurements.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04653129
Brief Title
Autologous Fat in Peripheral Nerve Injury
Official Title
Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Injury
Keywords
fat graft, autologous fat, peripheral nerve injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (A): Primary nerve repair with autologous fat graft
Arm Type
Experimental
Arm Description
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
Arm Title
Group (B): Standard primary nerve repair
Arm Type
Active Comparator
Arm Description
Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.
Intervention Type
Procedure
Intervention Name(s)
Autologous Fat Grafting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Primary Nerve Repair
Intervention Description
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
Primary Outcome Measure Information:
Title
Modified British Medical Research Council, sensory grading
Description
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
Time Frame
6-12 months
Title
Modified British Medical Research Council, motor grading
Description
standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Nerve conduction study
Description
measure for amplitude of response, latency of response and velocity of response measurements.
Time Frame
6-12 months
Title
Disability of the Arm, Shoulder, and Hand (DASH) score
Description
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)
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed S Sharaf, MsC
Phone
01090619155
Ext
+2
Email
ahmed.sharaf90@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek A El-Gammal, MD
Organizational Affiliation
Assiut University Hospital - Orthopaedics & Traumatology Dept.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Youssef S Hassan, MD
Organizational Affiliation
Assiut University Hospitals - Plastic Surgery Dept.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Awny M Asklany, MD
Organizational Affiliation
Assiut University Hospitals - Plastic Surgery Dept.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed S Sharaf, MsC
Organizational Affiliation
Assiut University Hospitals - Plastic Surgery Dept.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29710394
Citation
Di Summa PG, Schiraldi L, Cherubino M, Oranges CM, Kalbermatten DF, Raffoul W, Madduri S. Adipose Derived Stem Cells Reduce Fibrosis and Promote Nerve Regeneration in Rats. Anat Rec (Hoboken). 2018 Oct;301(10):1714-1721. doi: 10.1002/ar.23841. Epub 2018 Jul 10.
Results Reference
background
PubMed Identifier
20219599
Citation
Ngeow WC. Scar less: a review of methods of scar reduction at sites of peripheral nerve repair. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):357-66. doi: 10.1016/j.tripleo.2009.06.030. Erratum In: Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Aug;110(2):271.
Results Reference
background
PubMed Identifier
26273733
Citation
Tuncel U, Kostakoglu N, Turan A, Cevik B, Cayli S, Demir O, Elmas C. The Effect of Autologous Fat Graft with Different Surgical Repair Methods on Nerve Regeneration in a Rat Sciatic Nerve Defect Model. Plast Reconstr Surg. 2015 Dec;136(6):1181-1191. doi: 10.1097/PRS.0000000000001822.
Results Reference
background
PubMed Identifier
26773850
Citation
Walocko FM, Khouri RK Jr, Urbanchek MG, Levi B, Cederna PS. The potential roles for adipose tissue in peripheral nerve regeneration. Microsurgery. 2016 Jan;36(1):81-8. doi: 10.1002/micr.22480. Epub 2015 Sep 7.
Results Reference
background
PubMed Identifier
23653396
Citation
Kilic A, Ojo B, Rajfer RA, Konopka G, Hagg D, Jang E, Akelina Y, Mao JJ, Rosenwasser MP, Tang P. Effect of white adipose tissue flap and insulin-like growth factor-1 on nerve regeneration in rats. Microsurgery. 2013 Jul;33(5):367-75. doi: 10.1002/micr.22101. Epub 2013 May 7.
Results Reference
background
PubMed Identifier
19391342
Citation
Iannace C, Di Libero L, Manetta F, Sciascia V, Pizza A, Napolitano S, Ferraro A, Scetta G, Esposito D, Varriale S, Candela G, Caracciolo F. [Coleman lipofilling: experience of an Italian group and review of the literature]. Chir Ital. 2009 Jan-Feb;61(1):67-75. Italian.
Results Reference
background
PubMed Identifier
22411121
Citation
Vaienti L, Gazzola R, Villani F, Parodi PC. Perineural fat grafting in the treatment of painful neuromas. Tech Hand Up Extrem Surg. 2012 Mar;16(1):52-5. doi: 10.1097/BTH.0b013e31823cd218.
Results Reference
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Autologous Fat in Peripheral Nerve Injury
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