A Prospective Randomized Trial Comparing PopSole™ Offloading Device to Standard of Care Methods for the Reduction of Pain and Expedited Recovery in Patients Post Fat Graft Procedure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Ultrasonography
研究概览
简要总结
Study goals are to determine if a novel post-surgical foot offloading device can reduce post-operative pain and expedite the return to daily activity following fat grafting. Investigators will perform a prospective, randomized study utilizing PopSole™, a novel fully customizable post-operative shoe insert, to aid in the recovery of patients post-surgical fat graft injections for pain and limited activity due to foot disorders (ie. fat pad atrophy of the forefoot, heel, or for chronic plantar fasciitis).
Standard of care fat grafting is often used in plastic surgery for cosmetic or reconstructive reasons. Foot fat grafting, though not considered part of this research trial, is routinely offered in the UPMC Aesthetic Plastic Surgery center as a cosmetic surgery option; however, treatment modality options following the completion of a foot fat grafting procedure to protect the fat grafts and reduce weight bearing on the fresh fat grafts are limited. Current standard of care options including crutches, scooters, bulky post-operative shoes (ie. Darco shoes [Darco Intl. Huntington WV.]), and the addition of padding to insoles or orthotics that attempt to offload the treated area. Most of these devices are flat and provide poor anatomical support, leading to compensatory gait issues which can lead to further problems and pain in the knees, hips, and back. The most common complication with post-operative foot gear is non-compliance: patients do not wear it.
The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where the fat has been injected into the foot, as well as allow for customizable arch support and elevation of the metatarsals. By randomizing patients to recovery with standard methods versus this new device, the investigators are hopeful for earlier patient ambulation and return to work with decreased pain.
详细描述
Subjects will complete the following screening research procedures:
- Baseline reported outcome measures (PROMs) questionnaires and surveys that will take approximately 25 minutes to complete:
- Foot and Ankle Ability Measure (FAAM) questionnaire to assess subject ADL and function ability
- Mayo Clinical Scoring System questionnaire (MAYO) to assess subject pain, activity and function
- American Orthopaedic Foot and Ankle Society questionnaire (AOFAS) to assess subject pain and function
- Manchester Foot and Ankle Disability Index to assess subject foot pain/discomfort
- Pittsburgh Foot Survey to assess subject pain, activity, life satisfaction/quality of life
- Offload Device Survey to assess the ease and comfort of the offload device
- Foot ultrasounds will be performed to assess and measure baseline thickness of the plantar fascia, forefoot, or heel.
- 2D Photographs of both feet will be performed for a visual baseline assessment skin and soft tissue thickness.
If the clinical fat graft procedure occurs on a day different from the screening visit, the following research activities will be completed at Visit 2 if the subject continues to remain interested and eligible for study participation:
- Collection of subject's vital signs (Temp, HR, Resp., BP), medication profile, allergies, weight, BMI calculation and adverse event collection and reporting.
- Medical and surgical history collection review - the Investigator will confirm that the subject's medical status has not changed since last seen and the subject continues to satisfy eligibility criteria for study intervention.
- Performance of a limited physical and foot exam by PI and /or Co-investigator MD
- Women of childbearing potential will receive a urine pregnancy dip test with results documented to study chart.
- Diary cards with instruction to start entry on the diary card 24 hours after the fat grafting surgery to continue through Post-operative Visit 4 (Month 1) and be placed to study chart. The subject will be instructed to document self-assessment of the following events pertaining to the surgical site: Pain, Bruising, Redness of the skin, Itching, Swelling, Bleeding, Other (any concerns/issues not listed). The subject will be instructed to identify on the diary card the location, date and day of each documented event. Unresolved events at Visit 4 will be carried over for documentation to the adverse event log.
- 2D Photographs of both feet
- Offload Device Distribution to remain in use at all times during ambulation and activity instruction to stay off of feet as much as possible for 3 days, then limit ambulation to 10 minutes per hour for 4 weeks and no sports, kicking, running or exercise for 4 weeks. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Aged 18 years or older and able to provide informed consent
- •Subjects scheduled to undergo a standard of care treatment with fat grafting for foot pain due to forefoot or heel fat pad atrophy or chronic plantar fasciitis as defined by heel pain for greater than 6 months and failed non-surgical therapy
- •Willing and able to comply with follow up examinations, including ultrasounds
排除标准
- •Concurrent injury to the lower extremity that would effect gait
- •Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
- •Surgical foot intervention in the last 6 months
- •Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
- •Any issue that per the physician's determination would render the patient not appropriate to continue participation in the study (compliance, change in physical status, etc.)
研究组 & 干预措施
Intervention
Pedal fat grafting followed by PopSole™ offloading device
干预措施: PopSole™ offloading device (Device)
Standard of care
Pedal fat grafting followed by standard post-operative care with padding of the insoles
干预措施: padded insole (Device)
结局指标
主要结局
Ultrasonography
时间窗: 6 months post-op
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Pittsburgh Foot Survey
时间窗: 6 months post-op
Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results
Foot and Ankle Ability Measure (FAAM) questionnaire
时间窗: 6 months post-op
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
时间窗: 6 months post-op
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Mayo Clinical Scoring System questionnaire (MAYO)
时间窗: 6 months post-op
Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)
Manchester Foot and Ankle Disability Index
时间窗: 6 months post-op
Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).
Ultrasonography
时间窗: at screening
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Ultrasonography
时间窗: 1 month post-op
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Ultrasonography
时间窗: 2 months post-op
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
时间窗: at screening
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
时间窗: 1 month post-op
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
时间窗: 2 months post-op
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Pittsburgh Foot Survey
时间窗: at screening
Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results
Pittsburgh Foot Survey
时间窗: 1 month post-op
Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results
Pittsburgh Foot Survey
时间窗: 2 months post-op
Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results
Manchester Foot and Ankle Disability Index
时间窗: at screening
Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).
Mayo Clinical Scoring System questionnaire (MAYO)
时间窗: 2 months post-op
Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)
Manchester Foot and Ankle Disability Index
时间窗: 1 month post-op
Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).
Manchester Foot and Ankle Disability Index
时间窗: 2 months post-op
Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).
Mayo Clinical Scoring System questionnaire (MAYO)
时间窗: at screening
Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)
Mayo Clinical Scoring System questionnaire (MAYO)
时间窗: 1 month post-op
Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)
Foot and Ankle Ability Measure (FAAM) questionnaire
时间窗: at screening
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Foot and Ankle Ability Measure (FAAM) questionnaire
时间窗: 1 month post-op
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Foot and Ankle Ability Measure (FAAM) questionnaire
时间窗: 2 months post-op
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
次要结局
- Offload Device Survey(2 months post-op)
- Offload Device Survey(2 weeks post-op)
- Offload Device Survey(at screening)
- Offload Device Survey(1 month post-op)
研究者
Jeffrey A. Gusenoff, MD
Professor of Plastic Surgery, University of Pittsburgh School of Medicine, Co-Director, Life After Weight Loss Program, Director, Foot Fat Grafting Institute
University of Pittsburgh