Tibial Delayed Healing Pivotal Clinical Trial

Stopped early · Phase 3

Conditions studied: Tibial Delayed Healing

In brief

Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.

Key facts

Study ID: NCT01016067
Run by: Medtronic Spinal and Biologics
People needed: 23
Starts: 2010-11-01
Expected to finish: 2013-12-01
Last updated by the study team: 2015-01-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Has tibial delayed healing. A subject will be considered to have delayed healing when he/she is at least six months from the date of the most recent surgical intervention and has shown no signs of radiographic healing for at least three months. (Radiographic signs of healing for this study are defined as either the progressive disappearance of fracture lines or the development of cortical continuity [bridging bone] at the site.)
Has delayed healing of the tibia that requires treatment with rigid internal fixation and bone grafting. (Stable rigid internal fixation hardware may already be in place prior to treatment. If required, the fixation hardware may be removed and replaced along with the placement of the bone graft.)
Has adequate soft tissue coverage at the delayed healing site. All prior soft tissue coverage procedures (e.g., skin grafts or flaps) should be sufficiently healed for placement of a bone graft prior to enrollment in the study.
Has a sufficient amount of iliac crest autograft available for a bone grafting procedure.
After walking 5 or 6 steps, has intensity of pain/discomfort at the injury site equal to or greater than 4 (as reported on the preoperative Delayed Healing Site Pain Questionnaire form; 0 being no pain and 10 being pain as bad as it could be).
Is at least 21 years of age and skeletally mature at the time of surgery.
If a female of child-bearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery in the study.
Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if…

Has a congenital pseudarthrosis or pathological fracture nonunion (not including osteoporosis-related fractures).
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.)
Has hypertrophic tibial delayed healing (e.g., observed on x-ray as having an abundant callus or "horse hoof" appearance).
Has inadequate neurovascular status in the involved limb that may jeopardize healing.
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.
Has existing stable hardware that will not be removed and does not meet the algorithm requirements.
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.
Has a tibial delayed healing injury site with a bony defect larger than 4 cm in length.
Has another injury/condition that prevents ambulation or completion of any of the study assessments.
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).
Has a Vitamin D deficiency, defined as a 25-hydroxy Vitamin D serum concentration of ≤11ng/mL .
Has an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
Has an overt or active systemic infection (e.g., HIV/AIDS, hepatitis, bacteremia).
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.
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.
Has a history of certain autoimmune diseases. (Refer to the List of Autoimmune Diseases in the CIP for further information.)
Has a history of exposure to injectable collagen or silicone implants.
Has any previous exposure to any recombinant BMPs of either human or animal extraction.
Has a history of hypersensitivity to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).
Has a history of allergy to bovine collagen products.
Has a documented allergy or intolerance to metal or metal alloys, such as stainless steel or titanium.
Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
Is mentally incompetent. If questionable, obtain psychiatric consult.
Is a prisoner.
Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.

Where it is running

Denver Health — Denver, Colorado, United States
Shrock Orthopedic Research — Fort Lauderdale, Florida, United States
University of Florida College of Medicine — Jacksonville, Florida, United States
Orlando Health — Orlando, Florida, United States
Fort Wayne Orthopaedics — Fort Wayne, Indiana, United States
Methodist Hospital — Indianapolis, Indiana, United States
Sinai Hospital of Baltimore — Baltimore, Maryland, United States
William Beaumont Hospital — Royal Oak, Michigan, United States
University of Missouri — Columbia, Missouri, United States
St. Louis University Hospital — St Louis, Missouri, United States
Lutheran Medical Center — Brooklyn, New York, United States
Carolinas Medical Center — Charlotte, North Carolina, United States
Ohio Health Research Center — Columbus, Ohio, United States
University of Oklahoma — Oklahoma City, Oklahoma, United States
Geisinger Clinic — Danville, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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