AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMcMaster University
About this trial
This is a pilot multi-centre RCT of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (AMIC) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. Follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients aged 18-55 years
Hip pain lasting 6 months or more with no relief from documented non-operative modalities
Focal articular cartilage defects of the acetabulum on MRI, confirmed to be full thickness (International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4) during arthroscopic examination
Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
Disqualifiers
Cartilage defects of the femoral head
Previous surgery on the study hip
Traumatic chondral injury of the hip from a single event
Presence of advanced osteoarthritis (Tonnis grade 3) or any other acute or chronic inflammatory joint disease
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous matrix-induced chondrogenesis (AMIC)
Procedure/SurgeryAMIC is a novel approach in which the microfracture technique has been enhanced by the use of a type I/III collagen matrix (Chondro-Gide®; Geistlich Pharma AG, Wolhusen, Switzerland). In this single-step procedure, the matrix is placed over the defect to stabilize the fragile blood clot that arises from microfracture and to provide infrastructure for repair tissue formation. Essentially, the matrix covers the defect and serves as a protective shield that contains the cells and minimizes the impact of shear forces when moving the hip on the delicate blood clot. At the same time, it functions as the roof of a biological chamber that forms over the defect. The biocompatible collagen material provides an environment for cell growth and is replaced by native tissue over time.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: MicrofractureActive comparator 1 intervention
Group B: Autologous matrix-induced chondrogenesis (AMIC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hip function and health-related quality of life using the International Hip Outcome Tool (iHOT-33)
The iHOT-33 is designed to measure hip-specific health-related quality of life changes after treatment of active young patients with hip disorders. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
Time frame
Change from baseline to 24 months post-surgerySecondary outcomes
1
Hip pain using the Visual Analogue Scale (VAS); 100-point scale
To measure hip pain. The total score is calculated as a single response ranging from 0 to 100, with 100 representing the worst possible pain.
Time frame
Change from baseline to 24 months post-surgery2
Cartilage repair using the Magnetic Resonance Evaluation of the Repair of Cartilage in the Hip Score (MERCH) (scored from 0-100)
To evaluate cartilage repair in the hip using MRI imaging. The total score is calculated as a simple mean of the responses ranging from 0 to 100, with 0 representing the worst cartilage status.
Time frame
Change from baseline to 24 months post-surgery3
Health utility using the Euro-Qol 5 Dimensions (EQ-5D); index score
Utility-based instrument for use as a measure of health outcome. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Time frame
Change from baseline to 24 months post-surgery4
Total number of adverse events
Any reported complications such as infection, additional or revision surgery, hypersensitivity or allergic reactions, and reduced range of motion
Time frame
24 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Geistlich Pharma AG
Collaborator
Source ClinicalTrials.gov