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

Osteochondral Lesion of Talus Clinical Trial

— OUTBACK  

Official title:

'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'

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04475341
• Other study ID #: GK2019OUTBACK
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 2, 2024

Study information

• Verified date: July 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jari Dahmen, MD, BSc
• Phone: +31638522988
• Email: j.dahmen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: September 2, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteochondral Lesion of Talus

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale of Pain During Weightbearing		2 years post-operatively
Secondary	EQ5D		pre-operatively
Secondary	EQ5D		three months postoperatively
Secondary	EQ5D		one-year post-operatively
Secondary	EQ5D		two years post-operatively
Secondary	AOFAS	American Orthopaedic Foot and Ankle Score (AOFAS)	preoperatively
Secondary	AOFAS	American Orthopaedic Foot and Ankle Score (AOFAS)	three months postoperatively
Secondary	AOFAS	American Orthopaedic Foot and Ankle Score (AOFAS)	one-year post-operatively
Secondary	AOFAS	American Orthopaedic Foot and Ankle Score (AOFAS)	two years post-operatively
Secondary	FAOS	Foot and Ankle Outcome Score	pre-operatively
Secondary	FAOS	Foot and Ankle Outcome Score	three months
Secondary	FAOS	Foot and Ankle Outcome Score	one-year post-operatively
Secondary	FAOS	Foot and Ankle Outcome Score	two years post-operatively
Secondary	NRS in rest	Numeric Rating Scale of Pain During Rest	pre-operatively
Secondary	NRS in rest	Numeric Rating Scale of Pain During Rest	3 months postoperatively
Secondary	NRS in rest	Numeric Rating Scale of Pain During Rest	1 year postoperatively
Secondary	NRS in rest	Numeric Rating Scale of Pain During Rest	2 years postoperatively
Secondary	NRS during running	Numeric Rating Scale of Pain During Running	pre-operatively
Secondary	NRS during running	Numeric Rating Scale of Pain During Running	3 months postoperatively
Secondary	NRS during running	Numeric Rating Scale of Pain During Running	1 year postoperatively
Secondary	NRS during running	Numeric Rating Scale of Pain During Running	2 years postoperatively
Secondary	NRS during stair-climbing	Numeric Rating Scale of Pain During Stair-Climbing	pre-operatively
Secondary	NRS during stair-climbing	Numeric Rating Scale of Pain During Stair-Climbing	3 months postoperatively
Secondary	NRS during stair-climbing	Numeric Rating Scale of Pain During Stair-Climbing	1 year postoperatively
Secondary	NRS during stair-climbing	Numeric Rating Scale of Pain During Stair-Climbing	2 years postoperatively
Secondary	NRS during performing sports	Numeric Rating Scale of Pain During Sports	pre-operatively
Secondary	NRS during performing sports	Numeric Rating Scale of Pain During Sports	3 months post-operatively
Secondary	NRS during performing sports	Numeric Rating Scale of Pain During Sports	1 year post-operatively
Secondary	NRS during performing sports	Numeric Rating Scale of Pain During Sports	2 years post-operatively
Secondary	NRS during weight-bearing	Numeric Rating Scale of Pain During Weightbearing	pre-operatively
Secondary	NRS during weight-bearing	Numeric Rating Scale of Pain During Weightbearing	3 months postoperatively
Secondary	NRS during weight-bearing	Numeric Rating Scale of Pain During Weightbearing	1 year post-operativley
Secondary	FAAM	Foot and Ankle Ability Measure	pre-operatively
Secondary	FAAM	Foot and Ankle Ability Measure	3 months postoperatively
Secondary	FAAM	Foot and Ankle Ability Measure	1 year postoperatively
Secondary	FAAM	Foot and Ankle Ability Measure	2 years postoperatively
Secondary	SF-12	Short-Form 12	pre-operatively
Secondary	SF-12	Short-Form 12	3 months postoperatively
Secondary	SF-12		1 year postoperatively
Secondary	SF-12	Short-Form 12	2 years postoperatively
Secondary	Ankle Activity Scale (AAS)		pre-operatively
Secondary	Ankle Activity Scale (AAS)		3 months postoperatively
Secondary	Ankle Activity Scale (AAS)		1 year post-operatively
Secondary	Ankle Activity Scale (AAS)		2 year post-operatively
Secondary	Return to sports		post-operatively until 2 years of follow-up post-operatively
Secondary	Return to work		post-operatively until 2 years of follow-up post-operatively
Secondary	Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)		pre-operatively
Secondary	Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)		2 weeks postoperatively
Secondary	Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)		1 year postoperatively
Secondary	Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)		2 years postoperatively
Secondary	Radiological outcomes: MRI scan (T2 relaxation times)		Pre-operatively
Secondary	Radiological outcomes: MRI scan (T2 relaxation times)		1 year post-operatively
Secondary	Radiological outcomes: MRI scan (T2 relaxation times)		2 years post-operatively
Secondary	Cost-effectiviness	all relevant clinical costs will be scored through a patient diary	From per-operatively to post-operatively at 2 years (one period)
Secondary	Cell-subset analysis	protein analyses will be performed by Sanquin	per-operatively
Secondary	Demographic data	all kinds of demographic data will be assessed (age, gender, etc.)	Pre-operatively
Secondary	Complications	all types of complications	From per-operatively to post-operatively at 2 years (one period)
Secondary	Re-operations	re-operations will be assessed	From per-operatively to post-operatively at 2 years (one period)