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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
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.
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.
Numeric Rating Scale of Pain During Weightbearing
Time frame: 2 years post-operatively
EQ5D
Time frame: pre-operatively
EQ5D
Time frame: three months postoperatively
EQ5D
Time frame: one-year post-operatively
EQ5D
Time frame: two years post-operatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Time frame: preoperatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Time frame: three months postoperatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Time frame: one-year post-operatively
AOFAS
American Orthopaedic Foot and Ankle Score (AOFAS)
Time frame: two years post-operatively
FAOS
Foot and Ankle Outcome Score
Time frame: pre-operatively
FAOS
Foot and Ankle Outcome Score
Time frame: three months
FAOS
Foot and Ankle Outcome Score
Time frame: one-year post-operatively
FAOS
Foot and Ankle Outcome Score
Time frame: two years post-operatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Time frame: pre-operatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Time frame: 3 months postoperatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Time frame: 1 year postoperatively
NRS in rest
Numeric Rating Scale of Pain During Rest
Time frame: 2 years postoperatively
NRS during running
Numeric Rating Scale of Pain During Running
Time frame: pre-operatively
NRS during running
Numeric Rating Scale of Pain During Running
Time frame: 3 months postoperatively
NRS during running
Numeric Rating Scale of Pain During Running
Time frame: 1 year postoperatively
NRS during running
Numeric Rating Scale of Pain During Running
Time frame: 2 years postoperatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Time frame: pre-operatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Time frame: 3 months postoperatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Time frame: 1 year postoperatively
NRS during stair-climbing
Numeric Rating Scale of Pain During Stair-Climbing
Time frame: 2 years postoperatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Time frame: pre-operatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Time frame: 3 months post-operatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Time frame: 1 year post-operatively
NRS during performing sports
Numeric Rating Scale of Pain During Sports
Time frame: 2 years post-operatively
NRS during weight-bearing
Numeric Rating Scale of Pain During Weightbearing
Time frame: pre-operatively
NRS during weight-bearing
Numeric Rating Scale of Pain During Weightbearing
Time frame: 3 months postoperatively
NRS during weight-bearing
Numeric Rating Scale of Pain During Weightbearing
Time frame: 1 year post-operativley
FAAM
Foot and Ankle Ability Measure
Time frame: pre-operatively
FAAM
Foot and Ankle Ability Measure
Time frame: 3 months postoperatively
FAAM
Foot and Ankle Ability Measure
Time frame: 1 year postoperatively
FAAM
Foot and Ankle Ability Measure
Time frame: 2 years postoperatively
SF-12
Short-Form 12
Time frame: pre-operatively
SF-12
Short-Form 12
Time frame: 3 months postoperatively
SF-12
Time frame: 1 year postoperatively
SF-12
Short-Form 12
Time frame: 2 years postoperatively
Ankle Activity Scale (AAS)
Time frame: pre-operatively
Ankle Activity Scale (AAS)
Time frame: 3 months postoperatively
Ankle Activity Scale (AAS)
Time frame: 1 year post-operatively
Ankle Activity Scale (AAS)
Time frame: 2 year post-operatively
Return to sports
Time frame: 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
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time frame: pre-operatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time frame: 2 weeks postoperatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time frame: 1 year postoperatively
Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
Time frame: 2 years postoperatively
Radiological outcomes: MRI scan (T2 relaxation times)
Time frame: Pre-operatively
Radiological outcomes: MRI scan (T2 relaxation times)
Time frame: 1 year post-operatively
Radiological outcomes: MRI scan (T2 relaxation times)
Time frame: 2 years post-operatively
Cost-effectiviness
all relevant clinical costs will be scored through a patient diary
Time frame: From per-operatively to post-operatively at 2 years (one period)
Cell-subset analysis
protein analyses will be performed by Sanquin
Time frame: per-operatively
Demographic data
all kinds of demographic data will be assessed (age, gender, etc.)
Time frame: Pre-operatively
Complications
all types of complications
Time frame: From per-operatively to post-operatively at 2 years (one period)
Re-operations
re-operations will be assessed
Time frame: From per-operatively to post-operatively at 2 years (one period)
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