Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
Tibial Delayed Healing
Procedure: Autograft bone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Multicenter Pivotal Clinical Trial of the INFUSE/MASTERGRAFT™ Delayed Healing Device With Rigid Internal Fixation in the Treatment of Tibial Delayed Healing|
- Overall Success [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]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.
- Radiographic Union Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]Radiographic union success (a component of overall success) was defined as complete disappearance of fracture lines or the presence of bridging bone across the delayed healing site as observed on at least three of the four cortices (anterior, posterior, medial, and lateral), using plain films. If there was more than one delayed healing fracture line, all fracture lines must have been united in order to be considered a successful fracture union.
- Success in Weight Bearing Ability [ Time Frame: 12 months ] [ Designated as safety issue: No ]Success in weight bearing ability (a component of overall success) was defined that subject was able to bear weight without severe pain on the affected limb. The subject was asked to stand, bearing full weight on the affected limb in a single-leg stance without ambulatory assistance for 10 seconds. If the subject was able to do so without severe pain, a positive (success) response was recorded. If the subject was either unable to stand on the affected limb in a single-leg stance or declined to do so because of limb weakness, poor balance, or severe leg pain, a negative (failure) response was documented.
- Success of Pain Status at the Delayed Healing Site [ Time Frame: 12 months ] [ Designated as safety issue: No ]After walking five or six steps, subjects rated their intensity of pain/discomfort at the delayed healing site using a numerical rating scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be". Subjects who were unable or declined to walk because of severe leg pain were considered to have a score of 10. Success for pain at the delayed healing site was defined as at least a 2-point improvement in pain from the pre-operative score. Success of pain status at the delayed healing site was a component of overall success.
- Success in Short Musculoskeletal Functional Assessment (SMFA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The SMFA is an assessment tool that measures a subject's overall function for a broad range of musculoskeletal injuries and disorders. The SMFA results were summarized into two components, the dysfunctional index and the bother index. Success for the SMFA assessment was defined as any improvement post-operatively as compared to the pre-operative condition.
- Success in Short Form 36-Item (SF-36) Health Survey [ Time Frame: 12 months ] [ Designated as safety issue: No ]SF-36 was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success was defined as any improvement in a subject's SF-36 PCS post-operatively as compared to the pre-operative condition.
- Number of Subjects Having Additional Surgical Procedure Classified as a Treatment "Failure" [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Subject who had a surgery after the original study treatment was classified as a treatment "failure" if the additional surgery or treatment occurred in the involved limb and affected the study treatment and/or its mechanism of action in relation to the diagnosis or condition of the subject that was the cause for having the original study treatment.
|Study Start Date:||November 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
INFUSE® (rhBMP-2) on an absorbable collagen sponge (ACS) and MASTERGRAFT® granules with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)
Active Comparator: Autograft bone
Patients received autograft bone with rigid internal fixation.
Procedure: Autograft bone
Autogenous bone graft with appropriate rigid internal fixation hardware (reamed IM nail or plate/screws)
Other Name: Autogenous bone graft
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016067
|United States, Colorado|
|Denver, Colorado, United States, 80204|
|United States, Florida|
|Shrock Orthopedic Research|
|Ft. Lauderdale, Florida, United States, 33316|
|University of Florida College of Medicine|
|Jacksonville, Florida, United States, 32209|
|Orlando, Florida, United States, 32806|
|United States, Indiana|
|Fort Wayne Orthopaedics|
|Fort Wayne, Indiana, United States, 46804|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65201|
|St. Louis University Hospital|
|St. Louis, Missouri, United States, 63104|
|United States, New York|
|Lutheran Medical Center|
|Brooklyn, New York, United States, 11220|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28204|
|United States, Ohio|
|Ohio Health Research Center|
|Columbus, Ohio, United States, 43215|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Danville, Pennsylvania, United States, 17822|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|