Tibial Delayed Healing Pivotal Clinical Trial

NCT01016067 | Terminated Phase 3 Results DMC

• 1 other identifier: Medtronic P07-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Tibial Delayed Healing

Keywords

Tibia; Tibial; Fracture; Nonunion; delayed; healing; iliac; crest; autograft; INFUSE; MASTERGRAFT; Fixation; Internal

Outcome Measures

Primary Outcomes (1)

• Overall Success

  Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as "implant-associated" or "implant/surgical procedure-associated" (device-related); 5.no additional surgical procedures classified as a failure.

  12 Months

Secondary Outcomes (6)

• Radiographic Union Success

  12 months

• Success in Weight Bearing Ability

  12 months

• Success of Pain Status at the Delayed Healing Site

  12 months

• Success in Short Musculoskeletal Functional Assessment (SMFA)

  12 months

• Success in Short Form 36-Item (SF-36) Health Survey

  12 months

Study Arms (2)

INFUSE/MASTERGRAFT

EXPERIMENTAL

Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.

Device: INFUSE/MASTERGRAFT

Autograft bone

ACTIVE COMPARATOR

Patients received autograft bone with rigid internal fixation.

Procedure: Autograft bone

Interventions

INFUSE/MASTERGRAFT DEVICE

INFUSE® (rhBMP-2) on an absorbable collagen sponge (ACS) and MASTERGRAFT® granules with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)

Also known as: INFUSE, MASTERGRAFT

INFUSE/MASTERGRAFT

Autograft bone PROCEDURE

Autogenous bone graft with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)

Also known as: Autogenous bone graft

Autograft bone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (16)

Denver Health

Denver, Colorado, 80204, United States

Location

Shrock Orthopedic Research

Fort Lauderdale, Florida, 33316, United States

Location

University of Florida College of Medicine

Jacksonville, Florida, 32209, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Missouri

Columbia, Missouri, 65201, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Lutheran Medical Center

Brooklyn, New York, 11220, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Ohio Health Research Center

Columbus, Ohio, 43215, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Scleroderma, Limited

Condition Hierarchy (Ancestors)

Wounds and Injuries; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Limitations and Caveats

This trial was terminated due to difficulty in patient recruitment. Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.

Results Point of Contact

• Title: Clinical Department
• Organization: Medtronic Spinal

msbkclinicalresearch@medtronic.com

1800-876-3133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: November 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 21, 2015
• Results First Posted: November 4, 2014

Record last verified: 2015-01

Locations

US (16)