Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success? (OUTBACK)

July 14, 2020 updated by: Jari Dahmen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

'A Randomized Clinical Trial on the Clinical Efficacy of Bone Marrow Stimulation Combined With the Insertion of Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Small Primary and Non-primary Talar Osteochondral Lesions'

Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic debridement and microfracture
  • OCL depth and/or diameter ≤ 15 mm on computed tomography medial-lateral and/or anterior-posterior
  • Age 18 years or older
  • Intact remaining articular cartilage of the joint Kellgren-Lawrence stage 0-1

Exclusion Criteria:

  • Concomitant OCL of the tibia
  • Ankle osteoarthritis grade 2 or 3 van Dijk et al. [53]
  • Ankle fracture < 6 months before scheduled arthroscopy
  • Inflammatory arthropathy (e.g Rheumatoid arthritis)
  • History of (or current) hemopoeitic disease or immunotherapy
  • Acute or chronic instability of the ankle
  • Use of prescribed orthopaedic shoewear
  • Other concomitant painful or disabling disease of the lower limb
  • Pregnancy
  • Implanted pacemaker
  • Participation in previous trials < 1 year, in which the subject has been exposed to radiation (radiographs or CT)
  • Patients who are unable to fill out questionnaires and cannot have them filled out
  • No informed consent
  • HIV positive or hepatitis B or C infection (based on the anamnesis of the patient)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BMS without BMAC
Procedure: BMS alone
Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
Experimental: BMS with BMAC
Biological: BMS + Bone Marrow Aspirate Concentrate
Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Numeric Rating Scale of Pain During Weightbearing
Time Frame: 2 years post-operatively
2 years post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EQ5D
Time Frame: pre-operatively
pre-operatively
EQ5D
Time Frame: three months postoperatively
three months postoperatively
EQ5D
Time Frame: one-year post-operatively
one-year post-operatively
EQ5D
Time Frame: two years post-operatively
two years post-operatively
AOFAS
Time Frame: preoperatively
American Orthopaedic Foot and Ankle Score (AOFAS)
preoperatively
AOFAS
Time Frame: three months postoperatively
American Orthopaedic Foot and Ankle Score (AOFAS)
three months postoperatively
AOFAS
Time Frame: one-year post-operatively
American Orthopaedic Foot and Ankle Score (AOFAS)
one-year post-operatively
AOFAS
Time Frame: two years post-operatively
American Orthopaedic Foot and Ankle Score (AOFAS)
two years post-operatively
FAOS
Time Frame: pre-operatively
Foot and Ankle Outcome Score
pre-operatively
FAOS
Time Frame: three months
Foot and Ankle Outcome Score
three months
FAOS
Time Frame: one-year post-operatively
Foot and Ankle Outcome Score
one-year post-operatively
FAOS
Time Frame: two years post-operatively
Foot and Ankle Outcome Score
two years post-operatively
NRS in rest
Time Frame: pre-operatively
Numeric Rating Scale of Pain During Rest
pre-operatively
NRS in rest
Time Frame: 3 months postoperatively
Numeric Rating Scale of Pain During Rest
3 months postoperatively
NRS in rest
Time Frame: 1 year postoperatively
Numeric Rating Scale of Pain During Rest
1 year postoperatively
NRS in rest
Time Frame: 2 years postoperatively
Numeric Rating Scale of Pain During Rest
2 years postoperatively
NRS during running
Time Frame: pre-operatively
Numeric Rating Scale of Pain During Running
pre-operatively
NRS during running
Time Frame: 3 months postoperatively
Numeric Rating Scale of Pain During Running
3 months postoperatively
NRS during running
Time Frame: 1 year postoperatively
Numeric Rating Scale of Pain During Running
1 year postoperatively
NRS during running
Time Frame: 2 years postoperatively
Numeric Rating Scale of Pain During Running
2 years postoperatively
NRS during stair-climbing
Time Frame: pre-operatively
Numeric Rating Scale of Pain During Stair-Climbing
pre-operatively
NRS during stair-climbing
Time Frame: 3 months postoperatively
Numeric Rating Scale of Pain During Stair-Climbing
3 months postoperatively
NRS during stair-climbing
Time Frame: 1 year postoperatively
Numeric Rating Scale of Pain During Stair-Climbing
1 year postoperatively
NRS during stair-climbing
Time Frame: 2 years postoperatively
Numeric Rating Scale of Pain During Stair-Climbing
2 years postoperatively
NRS during performing sports
Time Frame: pre-operatively
Numeric Rating Scale of Pain During Sports
pre-operatively
NRS during performing sports
Time Frame: 3 months post-operatively
Numeric Rating Scale of Pain During Sports
3 months post-operatively
NRS during performing sports
Time Frame: 1 year post-operatively
Numeric Rating Scale of Pain During Sports
1 year post-operatively
NRS during performing sports
Time Frame: 2 years post-operatively
Numeric Rating Scale of Pain During Sports
2 years post-operatively
NRS during weight-bearing
Time Frame: pre-operatively
Numeric Rating Scale of Pain During Weightbearing
pre-operatively
NRS during weight-bearing
Time Frame: 3 months postoperatively
Numeric Rating Scale of Pain During Weightbearing
3 months postoperatively
NRS during weight-bearing
Time Frame: 1 year post-operativley
Numeric Rating Scale of Pain During Weightbearing
1 year post-operativley
FAAM
Time Frame: pre-operatively
Foot and Ankle Ability Measure
pre-operatively
FAAM
Time Frame: 3 months postoperatively
Foot and Ankle Ability Measure
3 months postoperatively
FAAM
Time Frame: 1 year postoperatively
Foot and Ankle Ability Measure
1 year postoperatively
FAAM
Time Frame: 2 years postoperatively
Foot and Ankle Ability Measure
2 years postoperatively
SF-12
Time Frame: pre-operatively
Short-Form 12
pre-operatively
SF-12
Time Frame: 3 months postoperatively
Short-Form 12
3 months postoperatively
SF-12
Time Frame: 1 year postoperatively
1 year postoperatively
SF-12
Time Frame: 2 years postoperatively
Short-Form 12
2 years postoperatively
Ankle Activity Scale (AAS)
Time Frame: pre-operatively
pre-operatively
Ankle Activity Scale (AAS)
Time Frame: 3 months postoperatively
3 months postoperatively
Ankle Activity Scale (AAS)
Time Frame: 1 year post-operatively
1 year post-operatively
Ankle Activity Scale (AAS)
Time Frame: 2 year post-operatively
2 year post-operatively
Return to sports
Time Frame: post-operatively until 2 years of follow-up post-operatively
post-operatively until 2 years of follow-up post-operatively
Return to work
Time Frame: post-operatively until 2 years of follow-up post-operatively
post-operatively until 2 years of follow-up post-operatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time Frame: pre-operatively
pre-operatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time Frame: 2 weeks postoperatively
2 weeks postoperatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time Frame: 1 year postoperatively
1 year postoperatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time Frame: 2 years postoperatively
2 years postoperatively
Radiological outcomes: MRI scan (T2 relaxation times)
Time Frame: Pre-operatively
Pre-operatively
Radiological outcomes: MRI scan (T2 relaxation times)
Time Frame: 1 year post-operatively
1 year post-operatively
Radiological outcomes: MRI scan (T2 relaxation times)
Time Frame: 2 years post-operatively
2 years post-operatively
Cost-effectiviness
Time Frame: From per-operatively to post-operatively at 2 years (one period)
all relevant clinical costs will be scored through a patient diary
From per-operatively to post-operatively at 2 years (one period)
Cell-subset analysis
Time Frame: per-operatively
protein analyses will be performed by Sanquin
per-operatively
Demographic data
Time Frame: Pre-operatively
all kinds of demographic data will be assessed (age, gender, etc.)
Pre-operatively
Complications
Time Frame: From per-operatively to post-operatively at 2 years (one period)
all types of complications
From per-operatively to post-operatively at 2 years (one period)
Re-operations
Time Frame: From per-operatively to post-operatively at 2 years (one period)
re-operations will be assessed
From per-operatively to post-operatively at 2 years (one period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GK2019OUTBACK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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