Clinical Trials Logo

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 formally evaluated healing and return of function after an extracellular matrix device implantation in 17 male and female subjects participating at the University of Pittsburgh under the Department of Plastic and Reconstructive Surgery who suffer from injury with loss of skeletal muscle tissue.


Clinical Trial 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 evaluated healing and return of function after an extracellular matrix device implantation in 17 male and female subjects participating at the University of Pittsburgh under the Department of Plastic Surgery who suffer from injury with loss of skeletal muscle tissue. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01292876
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date December 2010
Completion date May 2015

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
Withdrawn NCT01497678 - Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) Coordinating Center 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