Trial Outcomes & Findings for Enhanced Bioscaffold for Volumetric Muscle Loss (NCT NCT04051242)
NCT ID: NCT04051242
Last Updated: 2025-04-25
Results Overview
The Foot and Ankle Ability Measure (FAAM) activities of daily living subscale asks respondents to report on whether their activity was limited in the last week due to difficulties with their foot/ankle. The self-assessment uses a 5-point Likert scale from, and has a 6th option, not applicable, if difficulties are not specific to the foot/ankle. Answer choices include No difficulty, slight difficulty, moderate difficulty, extreme difficulty or unable to do. There are two subscales, activities of daily living and sports. For activities of daily living maximum score is 84 and lowest possible score is 0. (For the sports scale the maximum is 28 and the lowest possible score is zero. Higher scores indicate less difficulty with performing the activities. The FAAM sub scores are not totaled together but reported separately). For this subject, due to his injury, the investigators are reporting the Activities of Daily Living Subscale.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Baseline, 6 month follow up
Results posted on
2025-04-25
Participant Flow
10 subjects were consented, and completed in person screening for the study. 7 subjects did not meet eligibility criteria. 3 subjects were found to be eligible to proceed to study surgical intervention. 2 subjects completed the study intervention and received XenMatrix AB. In 1 case, due to a delay from the COVID-19 closure to research at the University of Pittsburgh, the subject no longer met study eligibility, once research was permitted to start.
Participant milestones
| Measure |
XenMatrix AB Surgical Graft
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
XenMatrix AB Surgical Graft
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Enhanced Bioscaffold for Volumetric Muscle Loss
Baseline characteristics by cohort
| Measure |
XenMatrix AB Surgical Graft
n=10 Participants
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
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|---|---|
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Age, Continuous
|
38.3 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow upPopulation: Participant 005 completed the FAAM ADL at baseline, and at 6 months post surgical intervention/implantation of Xenmatrix AB graft.
The Foot and Ankle Ability Measure (FAAM) activities of daily living subscale asks respondents to report on whether their activity was limited in the last week due to difficulties with their foot/ankle. The self-assessment uses a 5-point Likert scale from, and has a 6th option, not applicable, if difficulties are not specific to the foot/ankle. Answer choices include No difficulty, slight difficulty, moderate difficulty, extreme difficulty or unable to do. There are two subscales, activities of daily living and sports. For activities of daily living maximum score is 84 and lowest possible score is 0. (For the sports scale the maximum is 28 and the lowest possible score is zero. Higher scores indicate less difficulty with performing the activities. The FAAM sub scores are not totaled together but reported separately). For this subject, due to his injury, the investigators are reporting the Activities of Daily Living Subscale.
Outcome measures
| Measure |
XenMatrix AB Surgical Graft
n=1 Participants
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
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|---|---|
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Extremity Function; as Reported by Participant During a Physical Therapy Evaluation, Pre and Post Study Surgical Intervention, Using the Foot and Ankle Ability Measure (FAAM), Activities of Daily Living (ADL) Subscale Score.
Baseline FAAM ADL Sub Score
|
69 score on a scale
|
|
Extremity Function; as Reported by Participant During a Physical Therapy Evaluation, Pre and Post Study Surgical Intervention, Using the Foot and Ankle Ability Measure (FAAM), Activities of Daily Living (ADL) Subscale Score.
6 month follow up FAAM ADL Sub Score
|
73 score on a scale
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow upPopulation: 005, completed both a presurgical/baseline and post-surgical 6 month follow up analysis.
Assessment of patient extremity mechanical strength in right and left knee, post implantation of XENMATRIX AB™ Surgical Graft; after skeletal muscle injury as determined by physical therapy assessment using knee flexion force, as measured by dynamometry using newtons. Knee flexion force was measured three times, at each timepoint, so both the mean and lowest and highest score are reported below.
Outcome measures
| Measure |
XenMatrix AB Surgical Graft
n=1 Participants
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
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|---|---|
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Extremity Strength in Right and Left Knee (as Measured by Dynamometry Using Newtons, in a Knee Flexion Force Exercise), Pre and Post Surgical Intervention at Baseline and 6 Month Follow up.
Baseline right knee flexion force
|
18.9 Force, units measured in newtons
Interval 14.5 to 23.6
|
|
Extremity Strength in Right and Left Knee (as Measured by Dynamometry Using Newtons, in a Knee Flexion Force Exercise), Pre and Post Surgical Intervention at Baseline and 6 Month Follow up.
baseline left knee flexion force
|
12.2 Force, units measured in newtons
Interval 9.9 to 13.6
|
|
Extremity Strength in Right and Left Knee (as Measured by Dynamometry Using Newtons, in a Knee Flexion Force Exercise), Pre and Post Surgical Intervention at Baseline and 6 Month Follow up.
6 month right knee flexion force
|
191.6 Force, units measured in newtons
Interval 183.4 to 199.1
|
|
Extremity Strength in Right and Left Knee (as Measured by Dynamometry Using Newtons, in a Knee Flexion Force Exercise), Pre and Post Surgical Intervention at Baseline and 6 Month Follow up.
6 month left knee flexion force
|
164.4 Force, units measured in newtons
Interval 131.4 to 183.4
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SECONDARY outcome
Timeframe: 9-11 monthsNumber of Participants with Infection with the Use of XENMATRIX AB™ Surgical Graft. Two participants received the XENMATRIX AB™ Surgical Graft, during their study surgical intervention.
Outcome measures
| Measure |
XenMatrix AB Surgical Graft
n=2 Participants
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
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|---|---|
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Number of Participants With Infection With the Use of XENMATRIX AB™ Surgical Graft
|
0 participants
|
Adverse Events
XenMatrix AB Surgical Graft
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
XenMatrix AB Surgical Graft
n=2 participants at risk
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval \[#K162193\] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma
XenMatrix™ AB Surgical Graft: Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
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|---|---|
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Skin and subcutaneous tissue disorders
parathesia of lower limb
|
100.0%
2/2 • Number of events 2 • Participants were followed after consent/enrollment for up to 11 months. Presurgical activities included screening, eligibility review and a preoperative visit within 30 days of surgical intervention (approximately 3-5 months). After surgical intervention was completed, participants were followed for an additional 6 months, with scheduled follow up visits at 1 month, 3 months, and 6 months post.
|
|
Musculoskeletal and connective tissue disorders
Pain in left thigh, mid quad
|
50.0%
1/2 • Number of events 1 • Participants were followed after consent/enrollment for up to 11 months. Presurgical activities included screening, eligibility review and a preoperative visit within 30 days of surgical intervention (approximately 3-5 months). After surgical intervention was completed, participants were followed for an additional 6 months, with scheduled follow up visits at 1 month, 3 months, and 6 months post.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, lower limb
|
50.0%
1/2 • Number of events 1 • Participants were followed after consent/enrollment for up to 11 months. Presurgical activities included screening, eligibility review and a preoperative visit within 30 days of surgical intervention (approximately 3-5 months). After surgical intervention was completed, participants were followed for an additional 6 months, with scheduled follow up visits at 1 month, 3 months, and 6 months post.
|
|
Skin and subcutaneous tissue disorders
numbness, lower limb
|
50.0%
1/2 • Number of events 2 • Participants were followed after consent/enrollment for up to 11 months. Presurgical activities included screening, eligibility review and a preoperative visit within 30 days of surgical intervention (approximately 3-5 months). After surgical intervention was completed, participants were followed for an additional 6 months, with scheduled follow up visits at 1 month, 3 months, and 6 months post.
|
|
Skin and subcutaneous tissue disorders
edema of left ankle
|
50.0%
1/2 • Number of events 1 • Participants were followed after consent/enrollment for up to 11 months. Presurgical activities included screening, eligibility review and a preoperative visit within 30 days of surgical intervention (approximately 3-5 months). After surgical intervention was completed, participants were followed for an additional 6 months, with scheduled follow up visits at 1 month, 3 months, and 6 months post.
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Additional Information
J. Peter Rubin, MD Principal Investigator and Endowed Chair of Plastic Surgery
University of Pittsburgh
Phone: 412-383-8080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place