Trial Outcomes & Findings for A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft (NCT NCT02161016)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

24 months

Results posted on

2015-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	map3 Allogeneic Bone Graft 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 Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	map3 Allogeneic Bone Graft 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Overall Study withdrawn by IRB	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	map3 Allogeneic Bone Graft n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

map3 Allogeneic Bone Graft

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

Robin Waite

RTI Surgical

Phone: 386-418-8888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60