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Trial Outcomes & Findings for Bone Marrow Aspirate Concentration in Posterior Cervical Fusion (NCT NCT02068547)

NCT ID: NCT02068547

Last Updated: 2021-03-02

Results Overview

Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (\<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

6 months, 12 months, 24 months

Results posted on

2021-03-02

Participant Flow

Participant milestones

Participant milestones
Measure
Autograft/DBM/Cadaver Allo
Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft) locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Autograft/BMAC
Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Overall Study
STARTED
4
4
Overall Study
COMPLETED
0
1
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Autograft/DBM/Cadaver Allo
Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft) locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Autograft/BMAC
Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Overall Study
Lost to Follow-up
3
3
Overall Study
Physician Decision
1
0

Baseline Characteristics

Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Surigical Best Practice
n=4 Participants
Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft) locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Group 2
n=4 Participants
Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Total
n=8 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=93 Participants
4 Participants
n=4 Participants
7 Participants
n=27 Participants
Age, Categorical
>=65 years
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Age, Continuous
53.09 years
n=93 Participants
59.75 years
n=4 Participants
56.42 years
n=27 Participants
Sex: Female, Male
Female
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
3 Participants
n=4 Participants
6 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=93 Participants
4 Participants
n=4 Participants
8 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
1 Participants
n=4 Participants
3 Participants
n=27 Participants
Race (NIH/OMB)
White
2 Participants
n=93 Participants
3 Participants
n=4 Participants
5 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United States
4 participants
n=93 Participants
4 participants
n=4 Participants
8 participants
n=27 Participants

PRIMARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Study was discontinued prior to data being analyzed.

Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (\<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Study was discontinued prior to data being analyzed.

Short Form 36 (SF-36) is a profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 Months

Population: Study was discontinued prior to data being analyzed.

Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.

Outcome measures

Outcome data not reported

Adverse Events

Surigical Best Practice

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wilson Z. Ray, MD

Washington University St. Louis

Phone: 314-362-9959

Results disclosure agreements

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