Trial Outcomes & Findings for rhBMP-2 Versus Autograft in Critical Size Tibial Defects (NCT NCT00853489)
NCT ID: NCT00853489
Last Updated: 2018-10-25
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
12 months post op
Results posted on
2018-10-25
Participant Flow
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
Participant milestones
| Measure |
Recombinant Bone Morphogenetic Protein 2
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
|
Autogenous Iliac Crest Bone Graft
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 Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Recombinant Bone Morphogenetic Protein 2
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
|
Autogenous Iliac Crest Bone Graft
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 Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
rhBMP-2 Versus Autograft in Critical Size Tibial Defects
Baseline characteristics by cohort
| Measure |
Recombinant Bone Morphogenetic Protein 2
n=16 Participants
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
|
Autogenous Iliac Crest Bone Graft
n=14 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12 • n=39 Participants
|
35 years
STANDARD_DEVIATION 12 • n=41 Participants
|
36 years
STANDARD_DEVIATION 12 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Count of participants
|
16 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 months post opPopulation: RUST scores were used to determine radiograpghic union at 52 weeks
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.
Outcome measures
| Measure |
Recombinant Bone Morphogenetic Protein 2
n=12 Participants
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
|
Autogenous Iliac Crest Bone Graft
n=11 Participants
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.
|
|---|---|---|
|
Fracture Healing (Union) at 12 Months
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 months post op.Population: Infection was decribed in protocol
Infection will be assessed based on the CDC criteria for deep and superficial infection.
Outcome measures
| Measure |
Recombinant Bone Morphogenetic Protein 2
n=16 Participants
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
|
Autogenous Iliac Crest Bone Graft
n=14 Participants
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.
|
|---|---|---|
|
Infection
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 mos post opPopulation: Hospital bills for bone graft surgery admission were available on 25 patients total
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.
Outcome measures
| Measure |
Recombinant Bone Morphogenetic Protein 2
n=12 Participants
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
|
Autogenous Iliac Crest Bone Graft
n=13 Participants
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.
|
|---|---|---|
|
Medical Cost
|
13033 dollars for total admission cost
Interval 9038.0 to 22041.0
|
7535 dollars for total admission cost
Interval 2480.0 to 22915.0
|
Adverse Events
Recombinant Bone Morphogenetic Protein 2
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Autogenous Iliac Crest Bone Graft
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Recombinant Bone Morphogenetic Protein 2
n=16 participants at risk
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
|
Autogenous Iliac Crest Bone Graft
n=14 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Infection
|
18.8%
3/16 • Number of events 3 • One year after enrollment
The definition of adverse events/SAE does not differ from clinicaltrials.gov
|
0.00%
0/14 • One year after enrollment
The definition of adverse events/SAE does not differ from clinicaltrials.gov
|
Other adverse events
| Measure |
Recombinant Bone Morphogenetic Protein 2
n=16 participants at risk
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
|
Autogenous Iliac Crest Bone Graft
n=14 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Non union
|
6.2%
1/16 • Number of events 1 • One year after enrollment
The definition of adverse events/SAE does not differ from clinicaltrials.gov
|
7.1%
1/14 • Number of events 1 • One year after enrollment
The definition of adverse events/SAE does not differ from clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place