Tibial Delayed Healing Pivotal Clinical Trial

Exclusion Criteria

• •1. Has a congenital pseudarthrosis or pathological fracture nonunion (not including osteoporosis-related fractures).
• •2. Has a tibial delayed healing with articular involvement (e.g., intra-articular). (The original fracture may have involved the joint, but the resulting delayed healing site may not involve the joint.)
• •3. Has hypertrophic tibial delayed healing (e.g., observed on x-ray as having an abundant callus or "horse hoof" appearance).
• •4. Has inadequate neurovascular status in the involved limb that may jeopardize healing.
• •5. Has an active or a known prior infection at the delayed healing site (e.g., the presence of purulent drainage from the site, prior positive cultures from the site, or evidence of active/prior osteomyelitis at the site). Enrolled subjects whose intra-operative cultures test positive for bacteria may remain in the study.
• •6. Has existing stable hardware that will not be removed and does not meet the algorithm requirements.
• •7. Has treatment planned for the delayed healing that does NOT include placement of a bone graft and/or rigid internal fixation consisting of a reamed intramedullary nail or plate/screws.
• •8. Has a tibial delayed healing injury site with a bony defect larger than 4 cm in length.
• •9. Has another injury/condition that prevents ambulation or completion of any of the study assessments.
• •10. Has a history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroidism, parathyroid hormone disorder, Ehler-Danlos syndrome, osteogenesis imperfecta, calcium imbalance).
• •11. Has a Vitamin D deficiency, defined as a 25-hydroxy Vitamin D serum concentration of ≤11ng/mL .
• •12. Has an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
• •13. Has an overt or active systemic infection (e.g., HIV/AIDS, hepatitis, bacteremia).
• •14. Has been on oral or injectable steroids for six weeks or more at time of enrollment. This does not include episodic steroid use; inhaled steroids; or steroid medication (e.g., Epidural Steroid Injections, Medrol DosePaks) specifically for the perioperative management of symptoms.
• •15. Has a condition requiring postoperative medications that could interfere with bone healing of the implant, such as steroids. This does not include low dose aspirin for prophylactic anticoagulation; routine perioperative anti-inflammatory drugs; episodic steroid use; or inhaled steroids.
• •16. Has a history of certain autoimmune diseases. (Refer to the List of Autoimmune Diseases in the CIP for further information.)
• •17. Has a history of exposure to injectable collagen or silicone implants.
• •18. Has any previous exposure to any recombinant BMPs of either human or animal extraction.
• •19. Has a history of hypersensitivity to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).
• •20. Has a history of allergy to bovine collagen products.
• •21. Has a documented allergy or intolerance to metal or metal alloys, such as stainless steel or titanium.
• •22. Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
• •23. Is mentally incompetent. If questionable, obtain psychiatric consult.
• •24. Is a prisoner.
• •25. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• •26. Has received treatment with an investigational therapy (drug, device, and/or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 12-month period following the study surgery