NCT02011295

Brief Summary

The purpose of this study is to determine the clinical efficacy of the application of bone marrow aspirate concentrate (BMAC) as a supplement to microfracture in the treatment of osteochondral lesions of the talus (OLTs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

August 16, 2019

Status Verified

July 1, 2019

Enrollment Period

5.4 years

First QC Date

December 10, 2013

Last Update Submit

August 15, 2019

Conditions

Osteochondral Lesions of Talus

Keywords

OLTSurgical InterventionBMAC

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Assessment

    Visual Analog Scale (VAS)

    pre-operative up to 2yrs post surgery

  • Change in Functional Assessment

    Foot and Ankle Disability Index

    pre-operative to 2yrs post surgery

Secondary Outcomes (3)

  • Change in Functional Assessment

    pre-operative through 2yrs post surgery

  • Change in Functional Assessment

    pre-operative through 2yrs post surgery

  • MRI Assessment

    1 year post surgical intervention

Study Arms (2)

Microfracture

OTHER

Procedure/Surgery: ankle arthroscopy with debridement and microfracture of the OLT

Procedure: ankle arthroscopy with debridement and microfracture of the OLT

microfracture + injection of autologous BMAC

OTHER

Procedure/Surgery: ankle arthroscopy with debridement and microfracture of the OLT plus injection of autologous Bone Marrow Aspirate Concentration

Procedure: ankle arthroscopy with debridement and microfracture of the OLTOther: Bone Marrow Aspirate injection

Interventions

ankle arthroscopy with debridement and microfracture of the OLTPROCEDURE

ankle arthroscopy with debridement and microfracture of the OLT

Microfracturemicrofracture + injection of autologous BMAC
Bone Marrow Aspirate injectionOTHER
microfracture + injection of autologous BMAC

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over age 18
  • has an OLT that has not had previous surgical treatment

You may not qualify if:

  • OLT greater than 1.5cm in diameter (these require more extensive treatment)
  • more than one OLT
  • radiographic evidence of widespread ankle joint arthritis
  • any systemic inflammatory disease
  • any ankle deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Medical Plaza Page Road

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Interventions

Debridement

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Samuel B Adams, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 13, 2013

Study Start

January 29, 2014

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

August 16, 2019

Record last verified: 2019-07

Locations

US(1)