A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft

• Sponsor: RTI Surgical (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02161016
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.

Condition or Disease	Intervention/Treatment	Phase
Foot Deformities, Acquired; Disorder of Joint of Foot; Fracture of Foot; Deformity of Bone	Device: map3	Phase 4

Detailed Description

map3® Cellular Allogeneic Bone Graft provides the desired osteoconductive, osteoinductive and osteogenic potential capacities which are essential to optimal fracture healing when bone grafts are implanted. It offers viable MAPC-class cells on a scaffold comprised of demineralize bone matrix (DBM) and cortical cancellous chips. map3® Cellular Allogeneic Bone Graft is considered an allograft, and as such, is indicated for bone repair for orthopaedic indications where autograft is employed. The primary goal of this study is to evaluate the outcomes in bone grafts of the foot or ankle using a stem cell modified allograft (map3® Cellular Allogeneic Bone Graft). The study endpoints will be objectively determined via x-rays and CT scan to assess bony fusion, extremity evaluation using the AFAS and subjective patient scores for foot disabilities and quality of life.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Radiographic and Clinical Outcomes Study Evaluating map3® Cellular Allogeneic Bone Graft in Patients Undergoing Bone Grafting in the Foot/Ankle
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: map3 allogeneic bone graft Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.	Device: map3; Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.

Outcome Measures

Primary Outcome Measures

1. AOFAS Foot-and-Ankle Score [24 months]

   The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.

Secondary Outcome Measures

1. SF-36 Score [24 months]

   The SF-36 is a survey for health and well-being.

2. Foot Ankle Disability Index [24 months]

   The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.

3. CT Scan [6 months]

   A CT scan will be done at 6 months in order to assess bone fusion.

Other Outcome Measures

1. Time to Full Weight-bearing [up to 24 months]

   This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Study subjects will be limited to patients with foot/ankle pathologies requiring fusion, which include midfoot, hindfoot, ankle, double and triple arthrodesis using open surgical technique with supplemental bone graft substitute.

• Life expectancy of at least twenty four (24) months

• Ability to give written informed consent

• All subjects will have a minimum age of eighteen (18) years and a maximum of eighty (80) years.

• Both male and non-pregnant female subjects will be included.

• To facilitate follow-up, study subjects will be limited to the local geographic area of the study site and must be willing to use the rehabilitation facility and physical therapy schedule assigned by the surgeon.

• All subjects must be able to read, write, and comprehend instructions and guidelines in English and understand (and sign as an acknowledgment of their understanding) an informed consent declaration

Exclusion Criteria:

• Patients who have been diagnosed with Charcot foot

• Patients requiring osteotomies or undergoing a revision surgery for non-union

• Patients with additional lower limb injuries requiring concomitant procedures not related to the current foot/ankle procedure

• Patients with soft tissue compromise involving open and/or infected wounds on the study limb

• Patients requiring any other bone grafting product other than study product (map3® Cellular Allogeneic Bone Graft) e.g. rhBMP2 (recombinant human bone morphogenetic protein 2).

• Patients with confirmed diagnosis of abnormal lower limb vasculature or peripheral vascular disease

• Patients with a high Body Mass Index ( BMI > 35)

• Diagnosis of osteonecrosis, metabolic bone diseases or gout

• Diabetic patients who are insulin dependent

• Patients who have received any treatment within the past 12 months which may interfere with bone metabolism (bisphosphonates and/or calcitonin).

• Patients using glucocorticoids > 10 mg/day

• Chronic use (≥ 90 days) of non-steroidal anti-inflammatory drugs (NSAIDS)

• Patients with active cancer or a history of any cancer

• Known allergies to Dimethyl Sulfoxide (DMSO) and/or Human Serum Albumin (HSA)

• Pregnant or lactating females or who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study

• Patients who have tested positive for HTLV, HIV, hepatitis B or hepatitis C, have rheumatoid arthritis, an autoimmune disease or are on chronic immunosuppressive medications

• Require chronic use (≥ 90 days) of anticoagulation therapy

• Active smokers unwilling to comply with surgeons instructions to stop smoking seven (7) days prior to surgery through three (3) month post-op visit

• History of alcohol or drug abuse within 90 days of screening

• Patients currently enrolled or have been enrolled in clinical studies evaluating investigational devices, pharmaceuticals or biologics within 90 days of enrollment.

• Patients unable to give written informed consent and any vulnerable patient population

• Inability to comply with all requirements of this investigation, as well as follow the instructions of the physician

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Francis Hospital	Roslyn	New York	United States	11576

Sponsors and Collaborators

• RTI Surgical

Investigators

• Principal Investigator: Craig Radnay, MD, Saint Francis Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Clements JR. Use of allograft cellular bone matrix in multistage talectomy with tibiocalcaneal arthrodesis: a case report. J Foot Ankle Surg. 2012 Jan-Feb;51(1):83-6. doi: 10.1053/j.jfas.2011.09.002. Epub 2011 Oct 20.
• Guyton GP, Miller SD. Stem cells in bone grafting: Trinity allograft with stem cells and collagen/beta-tricalcium phosphate with concentrated bone marrow aspirate. Foot Ankle Clin. 2010 Dec;15(4):611-9. doi: 10.1016/j.fcl.2010.09.003. Review.

• Responsible Party: RTI Surgical
• ClinicalTrials.gov Identifier: NCT02161016
• Other Study ID Numbers: map3-2014
• First Posted: Jun 11, 2014
• Last Update Posted: Apr 1, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Foot Deformities; Foot Deformities, Congenital; Joint Diseases; Foot Deformities, Acquired; Congenital Abnormalities

Study Results

Participant Flow

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	AOFAS Foot-and-Ankle Score
Description	The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Measure Participants	0

2. Secondary Outcome

Title	SF-36 Score
Description	The SF-36 is a survey for health and well-being.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Measure Participants	0

3. Secondary Outcome

Title	Foot Ankle Disability Index
Description	The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Measure Participants	0

4. Secondary Outcome

Title	CT Scan
Description	A CT scan will be done at 6 months in order to assess bone fusion.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Measure Participants	0

5. Other Pre-specified Outcome

Title	Time to Full Weight-bearing
Description	This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
Measure Participants	0

Adverse Events

Arm/Group Title	map3 Allogeneic Bone Graft
Arm/Group Description	Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
All Cause Mortality
	map3 Allogeneic Bone Graft
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	map3 Allogeneic Bone Graft
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	map3 Allogeneic Bone Graft
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.