Tibial Delayed Healing Pivotal Clinical Trial

NCT ID: NCT01016067

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-12-31

Brief Summary

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

Detailed Description

The purpose of this study is to evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing. A subject will be considered to have tibial 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. All prospective patients must require surgical treatment with rigid internal fixation [reamed IM nail or plate/screws] and bone grafting.

Conditions

Tibial Delayed Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INFUSE/MASTERGRAFT

Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.

Group Type: EXPERIMENTAL

INFUSE/MASTERGRAFT

Intervention Type: 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)

Autograft bone

Patients received autograft bone with rigid internal fixation.

Group Type: ACTIVE_COMPARATOR

Autograft bone

Intervention Type: PROCEDURE

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

Interventions

INFUSE/MASTERGRAFT

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

Intervention Type: DEVICE

Autograft bone

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

Intervention Type: PROCEDURE

Other Intervention Names

INFUSE; MASTERGRAFT; Autogenous bone graft

Eligibility Criteria

Inclusion Criteria

1. 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.)

2. 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.)

3. 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.

4. Has a sufficient amount of iliac crest autograft available for a bone grafting procedure.

5. 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).

6. Is at least 21 years of age and skeletally mature at the time of surgery.

7. 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.

8. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

Medtronic P07-01

Identifier Type: -

Identifier Source: org_study_id