Collagen based -membrane derived from amniotic tissue can be used to help reestablish the natural synovial lining of the reconstructed ACL, in effect acting as both a barrier from the synovial fluid and as a scaffold to contain autologous mesenchymal stem cells and growth factors contiguous with the graft, thus aiding and perhaps accelerating the natural maturation and ligamentization process of the implanted graft tissue. Acceleration and improvement in graft maturation and strength would be a significant advancement in sports medicine allowing safer and earlier return to sports and activity
Histologic studies have determined that graft ligamentization following anterior cruciate ligament (ACL) reconstruction may take from 6 to 18 months. (1) It has been reported that incomplete graft maturation and incorporation is one cause of clinical graft failure. Animal studies have illustrated improved tendon healing/integration in ACL models augmented with stem cell technologies. (2-4). Basic scientists theorize that optimization of stem cell treatments for tissue regeneration requires that a "regenerative triad" be employed, i.e., use of a scaffold, stem cells and growth factors. In the intra-articular environment, research has shown that a scaffold such as an amnion wrap is necessary to contain the stem cells and growth factors in close proximity to the ACL graft. (2, 4, 5) The normal, uninjured human ACL is covered by a layer of synovial tissue which contributes to the blood supply and nutrition of the native ACL. It is theorized that the lack of a synovial lining after injury and following traditional ACL reconstruction contributes to slow ligamentization and possible failure of reconstructed grafts.(5) Two studies have demonstrated accelerated maturation and ligamentization of human ACL graft augmented with point of care blood products. (6, 7) In one, leucocyte poor platelet rich plasma was injected directly into the body of the graft. (6) In the other, the platelet derived growth factors were loaded in a gelatin carrier which was wrapped around the graft. (7) In both studies accelerated and increased ligament maturation was documented compared to the controls. Collagen membranes derived from amniotic tissue have been successful to aid healing when used in difficult wounds and meniscal repair surgery. (8, 9) The use of a collagen based -membrane derived from amniotic tissue may be used to help reestablish the natural synovial lining of the reconstructed ACL, in effect acting as both a barrier from the synovial fluid and as a scaffold to contain autologous mesenchymal stem cells and growth factors contiguous with the graft. Thus aiding and perhaps accelerating the natural maturation and ligamentization process of the implanted graft tissue. Acceleration and improvement in graft maturation and strength would be a significant advancement in sports medicine allowing safer and earlier return to sports and activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Bone marrow aspirate will be centrifuged using the Arthrex Angel system to optimally concentrate the cells for implantation. The graft for the experimental groups will be wrapped with a sterile amnion matrix wrap, supplied by Arthrex
Normal ACL reconstruction technique with either patella or hamstring autograft
Andrews Institute
Gulf Breeze, Florida, United States
Changes in ACL
MRI region of interest mapping to produce mean T2 values
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in patient-reported pain rating
Visual analog scale will be used to assess pain
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
Patients will complete KOOS questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in Short Form 12 (SF-12) patient ratings
Patients will complete SF-12 questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function
Patients will complete the SANE questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Marx Activity Scale Rating
Patients will complete the Marx Activity questionnaire on SOS
Time frame: 12 months post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.