BMAC: Bone Marrow Aspirate Concentration in Posterior Cervical Fusion

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02068547
• Collaborator: Harvest Technologies (Industry)
• Enrollment: 8
• Locations: 2
• Arms: 2
• Actual Duration (Months): 38.1
• Patients Per Site: 4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this research is to test if that combining bone marrow aspirate (removing bone marrow with a needle) concentration with locally harvested (collected) autograft (patient's own bone from another part of the body) for use as the bone graft results in equal rates of a successful procedure (fusion), as compared to current best practice in high-risk patients undergoing posterior cervical fusion.

Hypothesis: Bone marrow aspirate concentration combined with locally harvested autograft results in equivalent rates of bony fusion, as compared to current best practice in high-risk patients undergoing posterior cervical decompression and fusion.

Condition or Disease	Intervention/Treatment	Phase
Cervical Myelopathy; Radiculopathy	Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograft; Biological: Bone Marrow Aspirate	N/A

Detailed Description

100 consecutive high-risk patients who meet the following inclusion criteria: are 18-75 years of age, require a cervical spine MRI as part of their standard of care show evidence of CSM, and have cervical alignment allowing posterior instrumented fusion. High-risk will be defined as having a diagnosis of rheumatoid arthritis, osteoporosis, current smoker, or BMI >30. Patients will be excluded if they have any MRI incompatible devices, have any prior cervical instrumentation, require an instrumented anterior cervical fusion, or have an underlying neurological condition affecting the cervical spine (MS, ALS, HIV).

Patients will be sequentially randomized to one of two treatment groups. Group I, will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft). Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. To assist with analysis, we will collect information from patients' hematology results, obtained per their standard of care pre-operative workup. All patients will be treated post-operatively at the discretion of the treating surgeon. All patients will follow-up at 6 weeks, 3 months, 6 months, 12 months, and 24 months. At the 6, 12, and 24-month follow-up all patients will undergo flexion/extension X-rays, fusion will be defined as less than 2 mm or motion. A cervical spine CT may also be obtained at 24 months on all patients to assess fusion at the discretion of the treating surgeon. All radiographic assessments of fusion will be made by a Washington University staff radiologist, blinded to patient treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Bone Marrow Aspirate Concentration in Posterior Cervical Fusion
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Apr 5, 2017
• Actual Study Completion Date: Apr 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 - Surigical Best Practice Group 1 will receive current best practice for posterior instrumented fusion (locally harvested autograft, demineralized bone matrix, and cadaveric allograft)	Biological: locally harvested autograft, demineralized bone matrix, and cadaveric allograft
Experimental: Group 2 - autograft/BMAC Group II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration.	Biological: Bone Marrow Aspirate

Outcome Measures

Primary Outcome Measures

1. Rate of Fusion [6 months, 12 months, 24 months]

   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.

Secondary Outcome Measures

1. Physical and Mental Health From Subject's Point of View [24 months]

   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.

2. Neck Pain Affects Every Day Activities [24 Months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age between 18 and 75

• Have at least one of the following high risk qualifications: BMI >30, Rheumatoid Arthritis, Osteoporosis, Current smoker

• Able to cooperate in the completion of standardized outcome measures (multiple questionnaires)

• Willing and able to comply with study protocol

• Symptomatic cervical myelopathy and/or radiculopathy

• Scheduled for cervical alignment, allowing management with a posterior approach

Exclusion Criteria:

• MRI incompatible device

• History of prior cervical instrumentation

• Requires an instrumented anterior cervical fusion

• History of underlying neurological condition affecting the cervical spine (MS, Amyotrophic Lateral Sclerosis, HIV)

• Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)

• History of previous cervical fusion at the operative site

• Pregnant

• Active malignancy

• Previous history of posterior cervical decompression

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis School of Medicine	Saint Louis	Missouri	United States	63110
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• Harvest Technologies

Investigators

• Principal Investigator: Wilson Z Ray, MD, Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 25, 2016

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02068547
• Other Study ID Numbers: 201308043
• First Posted: Feb 21, 2014
• Last Update Posted: Mar 2, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Washington University School of Medicine: posterior cervical fusion; posterior cervical decompression
• Additional relevant MeSH terms: Radiculopathy; Spinal Cord Diseases

Study Results

Participant Flow

Arm/Group Title	Autograft/DBM/Cadaver Allo	Autograft/BMAC
Arm/Group Description	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 II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Period Title: Overall Study
STARTED	4	4
COMPLETED	0	1
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Surigical Best Practice	Group 2	Total
Arm/Group Description	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 II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate	Total of all reporting groups
Overall Participants	4	4	8
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	4 100%	7 87.5%
>=65 years	1 25%	0 0%	1 12.5%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	53.09	59.75	56.42
Sex: Female, Male (Count of Participants)
Female	1 25%	1 25%	2 25%
Male	3 75%	3 75%	6 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	4 100%	4 100%	8 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 50%	1 25%	3 37.5%
White	2 50%	3 75%	5 62.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	4 100%	8 100%

Outcome Measures

1. Primary Outcome

Title	Rate of Fusion
Description	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.
Time Frame	6 months, 12 months, 24 months

Outcome Measure Data

Analysis Population Description

Study was discontinued prior to data being analyzed.

Arm/Group Title	Surigical Best Practice	Group 2
Arm/Group Description	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 II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Measure Participants	0	0

2. Secondary Outcome

Title	Physical and Mental Health From Subject's Point of View
Description	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.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Study was discontinued prior to data being analyzed.

Arm/Group Title	Surigical Best Practice	Group 2
Arm/Group Description	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 II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Measure Participants	0	0

3. Secondary Outcome

Title	Neck Pain Affects Every Day Activities
Description	Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Study was discontinued prior to data being analyzed.

Arm/Group Title	Surigical Best Practice	Group 2
Arm/Group Description	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 II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
Measure Participants	0	0

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	There were no adverse events to report.
Arm/Group Title	Surigical Best Practice		Group 2
Arm/Group Description	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 II, will receive locally harvested autograft and 20 cc of bone marrow aspirate concentration. Bone Marrow Aspirate
All Cause Mortality
	Surigical Best Practice		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Serious Adverse Events
	Surigical Best Practice		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Surigical Best Practice		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.