Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

rhBMP-2 Versus Autograft in Critical Size Tibial Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00853489
Recruitment Status : Terminated (Enrollment too slow)
First Posted : March 2, 2009
Results First Posted : March 13, 2018
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
Major Extremity Trauma Research Consortium
Information provided by (Responsible Party):
Thomas Revak, DO, St. Louis University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tibial Fractures
Interventions Device: recombinant bone morphogenetic protein 2
Procedure: Autogenous iliac crest bone graft
Enrollment 33
Recruitment Details  
Pre-assignment Details 34 consented One was inelgible at time of graft due to infection pre enrollment Two were outside study period One Administrative withdrawl Total randomized : 30
Arm/Group Title Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Hide Arm/Group Description

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

Bone will be harvested from the iliac crest and placed in the bone defect.

Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Period Title: Overall Study
Started 16 14
Completed 11 12
Not Completed 5 2
Reason Not Completed
Lost to Follow-up             5             2
Arm/Group Title Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft Total
Hide Arm/Group Description

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

Bone will be harvested from the iliac crest and placed in the bone defect.

Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
14
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
37  (12) 35  (12) 36  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
4
  25.0%
3
  21.4%
7
  23.3%
Male
12
  75.0%
11
  78.6%
23
  76.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Hispanic or Latino
2
  12.5%
3
  21.4%
5
  16.7%
Not Hispanic or Latino
14
  87.5%
11
  78.6%
25
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  18.8%
1
   7.1%
4
  13.3%
White
13
  81.3%
13
  92.9%
26
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16
 100.0%
14
 100.0%
30
 100.0%
Count of participants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
16
 100.0%
14
 100.0%
30
 100.0%
1.Primary Outcome
Title Fracture Healing (Union) at 12 Months
Hide Description

Union will be defined by:

1. Radiographic union as defined by the Radiographic union scale in tibia fractures (RUST) score, Radiographic evaluation will be assessed by blinded orthopaedic surgeons.

Time Frame 12 months post op
Hide Outcome Measure Data
Hide Analysis Population Description
RUST scores were used to determine radiograpghic union at 52 weeks
Arm/Group Title Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Hide Arm/Group Description:

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

Bone will be harvested from the iliac crest and placed in the bone defect.

Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Overall Number of Participants Analyzed 12 11
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
11
 100.0%
2.Secondary Outcome
Title Infection
Hide Description Infection will be assessed based on the CDC criteria for deep and superficial infection.
Time Frame 12 months post op.
Hide Outcome Measure Data
Hide Analysis Population Description
Infection was decribed in protocol
Arm/Group Title Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Hide Arm/Group Description:

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

Bone will be harvested from the iliac crest and placed in the bone defect.

Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Overall Number of Participants Analyzed 16 14
Measure Type: Count of Participants
Unit of Measure: Participants
3
  18.8%
0
   0.0%
3.Secondary Outcome
Title Medical Cost
Hide Description An economic evaluation will also be performed including the costs of iliac crest bone graft harvest and complications from the bone graft surgery and the cost of the Rh-BMP 2 and the biologic implant used in the treatment group.
Time Frame 12 mos post op
Hide Outcome Measure Data
Hide Analysis Population Description
Hospital bills for bone graft surgery admission were available on 25 patients total
Arm/Group Title Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Hide Arm/Group Description:

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

Bone will be harvested from the iliac crest and placed in the bone defect.

Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Overall Number of Participants Analyzed 12 13
Mean (Full Range)
Unit of Measure: dollars for total admission cost
13033
(9038 to 22041)
7535
(2480 to 22915)
Time Frame One year after enrollment
Adverse Event Reporting Description The definition of adverse events/SAE does not differ from clinicaltrials.gov
 
Arm/Group Title Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Hide Arm/Group Description

The patient will receive rhBMP-2 plus allograft chips in the bone defect site. Intervention type: surgical

recombinant bone morphogenetic protein 2: Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

Bone will be harvested from the iliac crest and placed in the bone defect.

Autogenous iliac crest bone graft: Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

All-Cause Mortality
Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      0/14 (0.00%)    
Surgical and medical procedures     
Infection  [1]  3/16 (18.75%)  3 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Infection definition described in protocol
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Recombinant Bone Morphogenetic Protein 2 Autogenous Iliac Crest Bone Graft
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      1/14 (7.14%)    
Surgical and medical procedures     
Non union  [1]  1/16 (6.25%)  1 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
[1]
Defined in protocol
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lisa Kaye Cannada
Organization: Saint Louis University
Phone: 3145778850 ext 7
EMail: LCannada@slu.edu
Layout table for additonal information
Responsible Party: Thomas Revak, DO, St. Louis University
ClinicalTrials.gov Identifier: NCT00853489    
Other Study ID Numbers: W81XWH-09-20108
15915 ( Other Identifier: Saint Louis University Institutional Review Board )
First Submitted: February 24, 2009
First Posted: March 2, 2009
Results First Submitted: February 14, 2018
Results First Posted: March 13, 2018
Last Update Posted: October 25, 2018