An interventional study of Superiority of augmented repairs and Fat degeneration of supraspinatus muscle in Rotator Cuff Tear and Fatty Atrophy, sponsored by Applied Biologics, LLC. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by Applied Biologics, LLC · Not applicable, Interventional, and Treatment
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction. A secondary injection will be administered at the time of repair in the supraspinatus muscle body medial to the musculotendonous junction.
Patients will be given a written explanation of the study and screened for inclusion and exclusion criteria. Included patients will have a repairable, full thickness rotator cuff tear limited to the supraspinatus and infraspinatus, confirmed by MRI. Patients with concomitant biceps tenotomy, tenodesis, arthroscopic subacromial decompression, and distal clavicle excision will be included. Patients with prior operations on the shoulder, partial thickness tears, subscapularis tears or labral tears requiring repair, irreparable supraspinatus tears, staged bilateral rotator cuff repairs, or concomitant suprascapular nerve decompression will be excluded. We will also exclude patients with co-morbid conditions requiring the use of corticosteroids. Patients who cannot have an MRI for medical reasons will also be excluded.
All participants will volunteer to enroll in the study by signing informed consent (Attachment B). All potential subjects will be over 18 years of age and capable of providing their own informed consent. Patients will be recruited from the patient populations of Dr. Edwards, Dr. Elkousy, Dr. Morris, Dr. Gombera and Dr Brown. The informed consent process will be conducted by the investigators, their staff, or their research associates (e.g., orthopedic surgery fellows), who will explain the purpose and methods of the study, the risks and benefits, and requirements of participation. Randomization to groups will occur following informed consent; patients will not know to which group they are assigned.
FlōGraft® Preparation Protocol 3.1 Store FlōGraft® at -65◦C or colder until immediately prior to use. 3.2 Remove box from cold storage, open exterior box and remove interior package containing vials.
3.3 Neither the interior dust cover nor the outside of the vial are sterile. Do not place either the interior package or the vial in sterile field.
3.4 Remove vials from packaging, place on non-sterile, secure, flat surface, or hold vial firmly in one hand allowing contents to thaw (3-7 minutes.) Hold vial upright to aspirate contents. Note: Allograft should be implanted immediately post-thaw, but not later than eight (8) minutes post-thaw.
3.5 Pierce the vial cap and draw thawed solution into syringe. Do not pressurize vial with air prior to extracting thawed FlōGraft® solution.
3.6 If needed, change needle size based on surgeon preference (18g to 23g.)
FlōGraft® Implantation 4.1 After the rotator cuff repair is completed, shut off water-flow to joint. Excess water in joint is drained through the skin incisions, creating a "dry" sub-acromial space.
4.2 Insert needle through skin incision or percutaneously. Under direct visualization, inject FlōGraft® directly into rotator cuff tissue at repair site in approximately 0.50 cc aliquots. Cover entire repair site.
4.3 Implant allograft into the cuff muscle more medially to the repair in 0.25-0.5 cc aliquots, as appropriate.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 260 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Applied Biologics, LLC is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Assess pain, function, and structural integrity of the rotator cuff at 3 months, 6 months, 1 year, and 2 years post-operation
Biological: Superiority of augmented repairs · Biological: Fat degeneration of supraspinatus muscle
MRI assessment the quantity and disposition of fat within the supraspinatus muscle body compared to pre-operation MRI, at 1 year and 2 years post-operation
Biological: Superiority of augmented repairs · Biological: Fat degeneration of supraspinatus muscle
4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
Also known as: FlōGraft®, Human amniotic fluid-derived allograft
4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
Also known as: FlōGraft®, Human amniotic fluid-derived allograft
Structural healing integrity
Improved structural healing is the best indication of long-term surgery success. The Sugaya grading system is a method to account for structural integrity of the rotator cuff following surgery with five possible classifications. Sugaya scale: type I indicating sufficient thickness with homogeneously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, the presence of a minor discontinuity; and type V, the presence of a major discontinuity. Types I-III indicate different levels of healing. The classification of each shoulder must be assessed using MRIs (grade determined by a blinded musculoskeletal radiologist).
Time frame: 1 year post-operation
Fatty degeneration
Musculoskeletal radiologists will also evaluate fatty degeneration of the rotator cuff at 1 year post-operatively from the MRI using the Global Fatty Degeneration Index (GFDI).
Time frame: 1 year post-operation
Structural healing integrity (2)
Improved structural healing is the best indication of long-term surgery success. The Sugaya grading system is a method to account for structural integrity of the rotator cuff following surgery with five possible classifications. Sugaya scale: type I indicating sufficient thickness with homogeneously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, the presence of a minor discontinuity; and type V, the presence of a major discontinuity. Types I-III indicate different levels of healing. The classification of each shoulder must be assessed using MRIs (grade determined by a blinded musculoskeletal radiologist).
Time frame: 2 years post-operation
Fatty degeneration (2)
Musculoskeletal radiologists will also evaluate fatty degeneration of the rotator cuff at 2 years post-operatively from the MRI using the Global Fatty Degeneration Index (GFDI).
Time frame: 2 years post-operation
Functional outcome
Functional outcomes will be assessed using the American Shoulder and Elbow Surgeons Score.
Time frame: Baseline
Functional outcome (2)
Functional outcomes will be assessed using the American Shoulder and Elbow Surgeons Score.
Time frame: 3 months post-operation
Functional outcome (3)
Functional outcomes will be assessed using the American Shoulder and Elbow Surgeons Score.
Time frame: 6 months post-operation
Clinically Assessed Re-tear
Any incidence of clinically assessed re-tear will be documented by the treating surgeon during routine postoperative follow-up clinic visits and examinations.
Time frame: 3 months post-operation
Clinically Assessed Re-tear (2)
Any incidence of clinically assessed re-tear will be documented by the treating surgeon during routine postoperative follow-up clinic visits and examinations.
Time frame: 6 months post-operation
Plan to share: No
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