Enhanced Bioscaffold for Volumetric Muscle Loss

NCT04051242 | Terminated Results DMC FDA Device

• 1 other identifier: STUDY19040344
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single center study conducted at the University of Pittsburgh designed to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after soft tissue trauma.

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 6 month follow up

• 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.

  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.

  Baseline, 6 month follow up

Secondary Outcomes (1)

• Number of Participants With Infection With the Use of XENMATRIX AB™ Surgical Graft

  9-11 months

Study Arms (1)

XenMatrix AB Surgical Graft

EXPERIMENTAL

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

Device: XenMatrix™ AB Surgical Graft

Interventions

XenMatrix™ AB Surgical Graft DEVICE

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).

XenMatrix AB Surgical Graft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 70 years of age and able to provide informed consent
• Civilian, and current or former military personnel are eligible to participate
• Have suffered injury resulting in a structural deficit of a minimum of 20% of the muscle group mass and a functional deficit of a minimum of 25% when compared to a contralateral limb present; or if bilateral injury is present to extremities, the potential surgical extremity is to be compared against normal expected values of a sample population of similar age and gender and evidence of remaining tendon and musculotendinous units that could be surgically repaired with sutures.
• Injuries may encompass a single muscle belly or compartment, whether an area is expected to be repaired by sutures will be determined from imaging studies and physical examination. Muscle groups which originate or attach to the long bones of the extremity, and which directly affect strength and function (i.e., Pectoralis Major, Coracobrachialis, Subscapularis, Teres Major/Minor, Latissimus Dorsi, Supraspinatus, Infraspinatus, Gluteus group, Tensor fasciae latae, Piriformis, and quadratus femoris) will also be included in this clinical trial.
• Have suffered traumatic injury within the last 18 months to the upper and/or lower extremity; Target of 18 months or less but subject's may be enrolled with injury outside this range if the principal investigator determines that there is viable muscle in the injured compartment determined by clinical exam and imaging studies.
• Eligible for study procedures 3 months post injury with stability determined by the Principal Investigator and/ or Physician Co-Investigator
• Willing and able to comply with follow up examinations, radiographic studies, physical therapy, muscle biopsy and laboratory tests.

You may not qualify if:

• Inability to provide informed consent
• Poor nutrition (demonstrated by clinically significant abnormal lab results for serum albumin and pre-albumin values, per the investigator's discretion)
• Chronic disease such as congestive heart failure, liver disease, renal disease, or diabetes
• Active and unstable disease state or infection anywhere in the body per Physician's evaluation and determination (demonstrated by stated or medical record history and abnormal lab range for CBC with Differential and Platelet, Liver function and chemistry panel values)
• Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
• Pregnancy (demonstrated by a positive result of a urine pregnancy test)• Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
• Subjects with an Axis I diagnosis DSM-IV (e.g., Schizophrenia, 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
• Subjects with complete muscle/tendon gaps greater than 5 cm that are obvious on imaging studies and are unlikely to be reasonably repaired with sutures and reinforcement, and will be excluded. The investigators recognize that these findings may not be clear on imaging studies, and that the clinical judgment of the surgeon shall be applied in each case.
• Subjects with a known hypersensitivity to porcine serum products
• Allergies to the antibiotics, Rifampin, minocycline, tetracycline currently associated with the XenMatrix AB Surgical Graft
• Any condition or situation as it relates to the subject's health or safety, that would render concern to the investigators, and therefore preclude subject enrollment in the study.

Sponsors & Collaborators

• J. Peter Rubin, MD: lead
• United States Department of Defense: collaborator

Study Sites (1)

UPMC Aesthetic Plastic Surgery Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Dziki J, Badylak S, Yabroudi M, Sicari B, Ambrosio F, Stearns K, Turner N, Wyse A, Boninger ML, Brown EHP, Rubin JP. An acellular biologic scaffold treatment for volumetric muscle loss: results of a 13-patient cohort study. NPJ Regen Med. 2016 Jul 21;1:16008. doi: 10.1038/npjregenmed.2016.8. eCollection 2016.

  PMID: 29302336 BACKGROUND

• Han N, Yabroudi MA, Stearns-Reider K, Helkowski W, Sicari BM, Rubin JP, Badylak SF, Boninger ML, Ambrosio F. Electrodiagnostic Evaluation of Individuals Implanted With Extracellular Matrix for the Treatment of Volumetric Muscle Injury: Case Series. Phys Ther. 2016 Apr;96(4):540-9. doi: 10.2522/ptj.20150133. Epub 2015 Nov 12.

  PMID: 26564252 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Limitations and Caveats

Please note, there were not enough recruited eligible participants to measure significance. Results are presented from a single enrolled participant who received surgical intervention (graft implantation) on a left calf injury, and completed the 6 month physical therapy evaluation.

Results Point of Contact

• Title: J. Peter Rubin, MD Principal Investigator and Endowed Chair of Plastic Surgery
• Organization: University of Pittsburgh

rubipj@UPMC.EDU

412-383-8080

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: August 9, 2019
• Study Start: February 10, 2020
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)