Trial Outcomes & Findings for Comparing Synthetic Bone Alone Versus Synthetic Bone With Bone Marrow in Bone Lesions (NCT NCT00147823)

NCT ID: NCT00147823

Last Updated: 2015-06-08

Results Overview

Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2015-06-08

Participant Flow

Subjects seen by Dr. Damron in his clinical office were asked to participate, if they met the inclusion/exclusion criteria. Dates of recruitment February 2005, through August 2007

Participant milestones

Measure	Vitoss Alone No bone marrow aspirate used	Vitoss With Bone Marrow Aspirate Addition of Vitoss to the bone marrow aspirate Vitoss : Synthetic bone graft material
Overall Study STARTED	32	31
Overall Study Week 6 Visit	26	28
Overall Study Month 3 Visit	25	24
Overall Study Month 6 Visit	25	21
Overall Study Month 12 Visit	21	25
Overall Study Month 12 CT Scan	20	25
Overall Study Month 18 Visit	21	20
Overall Study Month 24 Visit	21	18
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Measure	Vitoss Alone No bone marrow aspirate used	Vitoss With Bone Marrow Aspirate Addition of Vitoss to the bone marrow aspirate Vitoss : Synthetic bone graft material
Overall Study Lost to Follow-up	6	12
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Did not receive vitoss due to infection	6	2

Baseline Characteristics

Comparing Synthetic Bone Alone Versus Synthetic Bone With Bone Marrow in Bone Lesions

Baseline characteristics by cohort

Measure	Vitoss Used With Bone Marrow Aspirate n=31 Participants Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate	Vitoss Only n=32 Participants Vitoss: Synthetic bone graft material alone	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants	17 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	17 Participants n=4 Participants	33 Participants n=27 Participants
Region of Enrollment United States	31 participants n=93 Participants	32 participants n=4 Participants	63 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this timepoint.

Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

Outcome measures

Measure	Vitoss n=18 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=19 Participants Vitoss alone, not bone marrow aspirate used
Resorption of Graft Material (GR) Compared at 24 Months	51 percentage of resorption Interval 0.0 to 100.0	47 percentage of resorption Interval 0.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs at this time point.

Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. .

Outcome measures

Measure	Vitoss n=18 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=19 Participants Vitoss alone, not bone marrow aspirate used
Bone Trabeculation Through the Defect (BT) Compared at 24 Months	95 percentage of trabeculation Interval 25.0 to 100.0	98 percentage of trabeculation Interval 25.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

Outcome measures

Measure	Vitoss n=17 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=17 Participants Vitoss alone, not bone marrow aspirate used
Resorption of Graft Material (GR) Compared at 18 Months	47 percentage of resorption Interval 0.0 to 100.0	44 percentage of resorption Interval 0.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.

Outcome measures

Measure	Vitoss n=17 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=17 Participants Vitoss alone, not bone marrow aspirate used
Bone Trabeculation Through the Defect (BT) Compared at 18 Months	90 percentage of trabeculation Interval 25.0 to 100.0	90 percentage of trabeculation Interval 25.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

Outcome measures

Measure	Vitoss n=23 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=19 Participants Vitoss alone, not bone marrow aspirate used
Resorption of Graft Material (GR) Compared at 12 Months	45 percentage of resorption Interval 0.0 to 100.0	42 percentage of resorption Interval 0.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.

Outcome measures

Measure	Vitoss n=23 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=19 Participants Vitoss alone, not bone marrow aspirate used
Bone Trabeculation Through the Defect (BT) Compared at 12 Months	42 percentage of trabeculation Interval 25.0 to 100.0	47 percentage of trabeculation Interval 25.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

Outcome measures

Measure	Vitoss n=19 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=24 Participants Vitoss alone, not bone marrow aspirate used
Resorption of Graft Material (GR) Compared at 6 Months	28 percentage of resorption Interval 0.0 to 75.0	25 percentage of resorption Interval 0.0 to 75.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.

Outcome measures

Measure	Vitoss n=19 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=24 Participants Vitoss alone, not bone marrow aspirate used
Bone Trabeculation Through the Defect (BT) Compared at 6 Months	31 percentage of trabeculation Interval 0.0 to 75.0	33 percentage of trabeculation Interval 0.0 to 75.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

Outcome measures

Measure	Vitoss n=21 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=25 Participants Vitoss alone, not bone marrow aspirate used
Resorption of Graft Material (GR) Compared at 3 Months	18 percentage of resorption Interval 0.0 to 75.0	22 percentage of resorption Interval 0.0 to 75.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.

Outcome measures

Measure	Vitoss n=21 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=25 Participants Vitoss alone, not bone marrow aspirate used
Bone Trabeculation Through the Defect (BT) Compared at 3 Months	8 percentage of trabeculation Interval 0.0 to 75.0	10 percentage of trabeculation Interval 0.0 to 75.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.

Outcome measures

Measure	Vitoss n=27 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=25 Participants Vitoss alone, not bone marrow aspirate used
Resorption of Graft Material (GR) Compared at 6 Weeks	6 percentage of resorption Interval 0.0 to 50.0	8 percentage of resorption Interval 0.0 to 50.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.

Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.

Outcome measures

Measure	Vitoss n=27 Participants Addition of Vitoss to the bone marrow aspirate Vitoss: Synthetic bone graft material	Vitoss Alone n=25 Participants Vitoss alone, not bone marrow aspirate used
Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks	4 percentage of trabeculation Interval 0.0 to 50.0	7 percentage of trabeculation Interval 0.0 to 50.0

Adverse Events

Vitoss Without Bone Marrow Aspirate

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Vitoss With Bone Marrow Aspirate

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitoss Without Bone Marrow Aspirate n=32 participants at risk subjects who received Vitoss without bone marrow aspirate	Vitoss With Bone Marrow Aspirate n=31 participants at risk subjects who received Vitoss with bone marrow aspirate
Respiratory, thoracic and mediastinal disorders pneumonia	6.2% 2/32 • Number of events 2 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	0.00% 0/31 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders Knee pain-persistent	6.2% 2/32 • Number of events 2 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	6.5% 2/31 • Number of events 2 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders recurrence of cyst	3.1% 1/32 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	6.5% 2/31 • Number of events 2 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders fracture of wrist	3.1% 1/32 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	0.00% 0/31 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders low back pain	3.1% 1/32 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	0.00% 0/31 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders bilateral leg weakness	3.1% 1/32 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	0.00% 0/31 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Skin and subcutaneous tissue disorders drainage at incision	6.2% 2/32 • Number of events 2 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	9.7% 3/31 • Number of events 3 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders femur pain	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders hip pain	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders shoulder pain	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders cervical neuropathy	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Skin and subcutaneous tissue disorders rash at incision	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders fracture of shoulder through lesion	3.1% 1/32 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	0.00% 0/31 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Musculoskeletal and connective tissue disorders fracture of femur through lesion	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.
Blood and lymphatic system disorders hematoma	0.00% 0/32 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.	3.2% 1/31 • Number of events 1 • 6 week, 3, 6, 12, 18 and 24 months Subjects were asked at their office visits if they had any new complications, any new diagnosis/treatments, also if records were received from another physician, this information was collected.

Additional Information

Timothy A. Damron, MD

SUNY Upstate Medical University

Phone: 315-464-8604

Email: damront@upstate.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place