Enriched Autologous Fat Grafting for Treating Pain at Amputation Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Treatment of Painful Amputation Sites
研究概览
简要总结
The objective of this pilot study is to assess the efficacy of minimally invasive autologous fat transfers at the amputation sites and the modulation of pain at the respective sites. Our investigators hypothesize that autologous fat grafting can provide a minimally invasive therapy to effectively mitigate pain syndromes at amputation sites, by introducing volume stable subcutaneous tissue over bony prominences and peripheral nerve trunks, thereby avoiding major surgical revisions and preserving limb length. The investigators further hypothesize that enriching the fat graft with autologous adipose stromal cells, a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.
The Investigators will evaluate:
- Treatment of painful amputation sites in 5 patients with fat grafting, intended to provide additional subcutaneous tissue padding over bony structures and nerve trunks. Limb anatomy and healing of the graft over time, along with stability/persistence of the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.
- Biologic properties of the cells within the fat graft and correlate with clinical outcomes. This will include adipose stem cell yield per volume of fat tissue, cell proliferation, capacity for adipogenic differentiation, lipolysis, and cell sub-population analysis by multiparameter flow cytometry. Results of these assays will be correlated with graft volume retention to search for predictors of good clinical outcome that are related to variation on adipose biology between subjects.
- Quality of life measurements in patients before and after autologous fat grafting using validated psychosocial measures. This will include SF 36, the Beck inventory, and instruments designed for assessing limb function.
详细描述
Traumatic amputations are prevalent and pose many challenges for our wounded warriors. A recent publication reported that during the current conflicts, over 950 military personnel have sustained combat-related amputations, with 15% of them occurring more than 12 weeks after initial injury (1). Updated statistics place this number of amputees at over 1050 (personal communication, COL Paul Pasquina, Chief of the Integrated Department of Orthopaedics and Rehabilitation, Walter Reed National Military Medical Center-WRNMMC). The ability of a wounded warrior to gain optimal function after an amputation most often depends on his or her ability to successfully fit and adapt to a prosthesis. Once out of the acute phase, many patients with amputations suffer from pain when wearing a prosthesis, either from thin soft tissue cover over bony structures or peripheral nerves not well padded with soft tissue. Extrinsic residual limb pain is usually mechanical in origin related to the prosthetic socket or other prosthetic components. It is often the result of a mismatch between residual limb tissue tolerance and the prosthetic loads on the soft tissues. This sensitivity is often accentuated by superficial nerve trunks or neuromas at severed nerves that are exposed to excessive external mechanical loading (2). Poor socket interface, secondary skin breakdown, and/or pain may severely limit function.
This presents a very difficult clinical problem and historically, when possible, the clinical procedure would be to involve the surgical revision of the amputation site with associated shortening of the bone, lengthy scars, and prolonged healing. If a below the knee amputation has to be converted to an above knee level, then there are serious functional implications. For local tissues at the amputation site that are of poor quality (e.g. scarred or covered with a skin graft), a distant muscle flap may be required (3,4). These flaps may require transfer to the amputation site using microvascular anastomosis of the blood vessels. The procedure is highly invasive and can add the morbidity of decreased function, deformity, and risk of wound healing problems at the muscle donor site. Failure rates in lower limb flaps can be as high as 18.5% (5, 6). Flap ulceration rates tend to be higher in these weight-bearing flaps, both skin and muscle free flaps frequently need secondary debulking procedures to improve function, and painful neuromas are not uncommon (6,7).
A clinical solution that allows for the minimally invasive generation of new soft tissue padding at an amputation site without the need for further limb shortening, lengthy scars, a prolonged recovery, and significant donor site morbidity would have the potential to significantly help our wounded warriors and change clinical practice.
Autologous fat grafting as a potential solution. Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 5mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the donor site. This surgical procedure involves the immediate transplantation of a patient's own tissue in a single operative procedure. It has the advantages of:
- Minimal access incisions
- Ability to transfer significant amounts of tissue (hundreds of grams of tissue)
- Can be used in setting of previous surgical procedures and presence of hardware
- Usually performed as outpatient procedure
- Minimal donor site morbidity at graft harvest site
- Low risk compared with more invasive surgical procedures
- Can be repeated multiple times, if necessary, even using the same donor sites
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older and able to provide informed consent
- •Have suffered injury resulting in an amputation with pain that limits the fitting and use of a prosthesis, despite maximal attempts to refit the prosthesis and/or change the design of the prosthesis
- •Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
- •Soft tissue deficiencies are noted at amputation stump and are covered by intact skin
- •Willing and able to comply with follow up examinations, including radiographic studies
- •Active military
- •Able to provide informed consent
排除标准
- •Age less than 18 years
- •Patient has inability to provide informed consent process.
- •Amputated limb area intended for treatment has open wounds, tunneling or drainage with active infection unresolved with one course of antibiotic treatment.
- •Active infection anywhere in the body
- •Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
- •Known coagulopathy symptoms /diagnosis
- •Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
- •History of Diabetes Mellitus
- •History of severe peripheral arterial disease
- •Diagnosis of Schizophrenia or Bipolar Disorder (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion).
研究组 & 干预措施
Procedure/Surgery: Enriched Fat grafting
Enriched Fat grafting
干预措施: Procedure/Surgery: Enriched Fat grafting (Procedure)
结局指标
主要结局
Treatment of Painful Amputation Sites
时间窗: 26 months
1) Treat painful amputation sites in 5 patients with fat grafting, to provide additional subcutaneous tissue padding over bony structures and nerve trunks. Limb anatomy and healing of the graft over time, along with stability/persistence of the new tissue, will be assessed by high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes. Patients will be enrolled who have pain at an amputation site that limits function and/or interferes with the ability to use a prosthesis.
次要结局
- Quality of Life improvement(26 months)
- Assessment of biological cell properties within fat graft(20 years)
研究者
J. Peter Rubin, MD
Principal Investigator
University of Pittsburgh
