Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01497678
Other study ID # PRO11050209
Secondary ID
Status Withdrawn
Phase N/A
First received August 9, 2011
Last updated October 19, 2016
Start date March 2013
Est. completion date November 2014

Study information

Verified date October 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

The objective of the study is to assess mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these subjects. This study will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 male and female subjects participating at 4-5 military sites who suffer from injury with loss of skeletal muscle tissue. The University of Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating Center for this multi-site study.


Description:

Loss of musculotendinous tissue as a result of trauma inevitably leads to severe morbidity for the subject and surgical challenges for the caregiver. The reconstruction of tissue following such injuries is often not possible and surgical options are extremely limited. Amputation of the affected limb is not an uncommon outcome. Free muscle grafts, pedicle grafts, and the use of prosthetic materials have all been attempted when primary repair is not possible due to loss of tissue domain. The results of such efforts are typically disheartening. If autologous grafts are used, donor site morbidity compounds the post surgical problems with resultant diminished quality of life. Stated differently, the existing treatment options for treatment of the loss of large amounts of skeletal muscle tissue with scarring are extremely limited because the existing tendon structures are damaged and lack strength. A Repair and Reinforcement approach with a biocompatible device would represent a paradigm shift in the treatment of traumatic tissue injury. This approach involves releasing scar tissue that constricts movement of the existing tendon, repairing damaged tendon and musculotendinous units with suture repair, and reinforcing the repair with a biologic scaffold material. The biologic scaffold is composed of animal derived collagen and the approved by the FDA as devices for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery." Additionally, as listed in the FDA 510k approval, these devices" provide a remodelable scaffold that is replaced by the subject's own soft tissues." These biologic materials fall into a category of implantable devices known as extracellular matrix (ECM) because they are composed of proteins that surround the cellular elements in mammals. No living cells are found in these ECM implantable devices. ECM devices are made by many commercial manufacturers and have been used for a variety of reconstructive surgical procedures for years. Because the ECM implant becomes populated with subject cells and blood vessels, the repair may be stronger and the new tissue growing within the device could possibly contribute to improved function by augmenting the tendon structure and allowing ingrowth of adjacent muscle fibers. The objective of the study is to assess mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these subjects. This study will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 male and female subjects participating at 4-5 military sties who suffer from injury with loss of skeletal muscle tissue. The University of Pittsburgh under the Department of Plastic Surgery is the Coordinating Center for this multi-site study.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with the following characteristics will be eligible to participate in the study:

- 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 the contralateral limb; 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.

- 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 MD Co-Investigator

- Willing and able to comply with follow up examinations, radiographic studies, physical therapy, muscle biopsy and laboratory tests.

Exclusion Criteria:

- Patients with the following characteristics will be excluded from participating in the study:

- Inability to provide informed consent

- Poor nutrition (demonstrated by abnormal lab range for serum Albumin and Pre-Albumin values)

- 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 MD's evaluation and determination (demonstrated by stated or medical record history and abnormal lab range for CBC with Differential and Platelet, 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

- 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Extracellular Matrix
Extracellular Matrix

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
University of Pittsburgh United States Naval Medical Center, Portsmouth, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (9)

Beattie AJ, Gilbert TW, Guyot JP, Yates AJ, Badylak SF. Chemoattraction of progenitor cells by remodeling extracellular matrix scaffolds. Tissue Eng Part A. 2009 May;15(5):1119-25. doi: 10.1089/ten.tea.2008.0162. — View Citation

Crisan M, Yap S, Casteilla L, Chen CW, Corselli M, Park TS, Andriolo G, Sun B, Zheng B, Zhang L, Norotte C, Teng PN, Traas J, Schugar R, Deasy BM, Badylak S, Buhring HJ, Giacobino JP, Lazzari L, Huard J, Péault B. A perivascular origin for mesenchymal stem cells in multiple human organs. Cell Stem Cell. 2008 Sep 11;3(3):301-13. doi: 10.1016/j.stem.2008.07.003. — View Citation

Holcomb JB, Stansbury LG, Champion HR, Wade C, Bellamy RF. Understanding combat casualty care statistics. J Trauma. 2006 Feb;60(2):397-401. — View Citation

Hostetler SG, Schwartz L, Shields BJ, Xiang H, Smith GA. Characteristics of pediatric traumatic amputations treated in hospital emergency departments: United States, 1990-2002. Pediatrics. 2005 Nov;116(5):e667-74. — View Citation

Mazurek MT, Ficke JR. The scope of wounds encountered in casualties from the global war on terrorism: from the battlefield to the tertiary treatment facility. J Am Acad Orthop Surg. 2006;14(10 Spec No.):S18-23. Review. — View Citation

Noe A. Extremity injury in war: a brief history. J Am Acad Orthop Surg. 2006;14(10 Spec No.):S1-6. — View Citation

Reing JE, Zhang L, Myers-Irvin J, Cordero KE, Freytes DO, Heber-Katz E, Bedelbaeva K, McIntosh D, Dewilde A, Braunhut SJ, Badylak SF. Degradation products of extracellular matrix affect cell migration and proliferation. Tissue Eng Part A. 2009 Mar;15(3):605-14. doi: 10.1089/ten.tea.2007.0425. — View Citation

Valentin JE, Badylak JS, McCabe GP, Badylak SF. Extracellular matrix bioscaffolds for orthopaedic applications. A comparative histologic study. J Bone Joint Surg Am. 2006 Dec;88(12):2673-86. — View Citation

Zantop T, Gilbert TW, Yoder MC, Badylak SF. Extracellular matrix scaffolds are repopulated by bone marrow-derived cells in a mouse model of achilles tendon reconstruction. J Orthop Res. 2006 Jun;24(6):1299-309. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mechanical strength and function The primary objective of the study is to assess mechanical strength and function of surgical extremity in patients undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these patients. Physical therapy evaluations of strength and active/passive range of motion and self-reported measures of ability to perform activities of daily living. Approximately 6 months post-operative Yes
Secondary Pathology Evaluation The secondary objective is to examine the cellular properties of the biopsy tissue material from the Extracellular Matrix surgical site for reabsorption and replacement by the subjects own soft tissue with pathological findings to be correlated with clinical outcomes. Approximately 6 months post-operative Yes
See also
  Status Clinical Trial Phase
Completed NCT05988476 - Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises N/A
Active, not recruiting NCT05344183 - Immediate and Short-term Effects of Low-level Laser N/A
Completed NCT05367648 - Effects of Protein Hydrolysate Supplement on Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects N/A
Not yet recruiting NCT05279196 - Biological Variables Associated With the Response to Intensive Training in Athletes N/A
Completed NCT05254470 - Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
Completed NCT03676205 - Platelet-Rich Plasma in Acute Muscle Injuries Phase 2
Completed NCT05827484 - The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries Phase 4
Completed NCT04177537 - Real-World Experience of Athletes Treated With SAM
Completed NCT01525667 - Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty Phase 1/Phase 2
Completed NCT04535635 - Effects of ART® on Lower Limb Myofascial Pain and Function N/A
Completed NCT04874662 - Nicotinamide (NAM) and Pyridoxine (Vitamin B6) on Muscle Regeneration ("Satellite-01 Study"). N/A
Completed NCT04742244 - Lemon Verbena Extract Oxidative Stress and Muscle Damage N/A
Active, not recruiting NCT04483986 - Does Rectus Re-approximation Cause Adhesion After Cesarean Section? N/A
Recruiting NCT06205537 - Muscle Health and Recovery in Older Adults N/A
Recruiting NCT05216666 - The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty N/A
Completed NCT02077413 - Muscle Injury Prevention & Rehabilitation in Military Personnel N/A
Terminated NCT01751503 - Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer N/A
Completed NCT04586712 - Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury Phase 2
Completed NCT04123782 - Focused Shockwave Treatment in the Recovery Process of Acute Muscle Injuries in Soccer Players N/A
Not yet recruiting NCT01097798 - To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. Phase 3