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

NCT04475341 | Unknown DMC

• 1 other identifier: GK2019OUTBACK
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteochondral Lesion of Talus

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale of Pain During Weightbearing

  2 years post-operatively

Secondary Outcomes (57)

• EQ5D

  pre-operatively

• EQ5D

  three months postoperatively

• EQ5D

  one-year post-operatively

• EQ5D

  two years post-operatively

• AOFAS

  preoperatively

Study Arms (2)

BMS without BMAC

ACTIVE COMPARATOR

Procedure: BMS alone

BMS with BMAC

EXPERIMENTAL

Biological: BMS + Bone Marrow Aspirate Concentrate

Interventions

BMS + Bone Marrow Aspirate Concentrate BIOLOGICAL

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.

BMS with BMAC

BMS alone PROCEDURE

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.

BMS without BMAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Central Study Contacts

Jari Dahmen, MD, BSc

CONTACT

+31638522988; j.dahmen@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, BSc

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 2, 2024
• Last Updated: July 17, 2020

Record last verified: 2020-07