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Compares treatment options for Hip Arthroscopy
Official title AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
ClinicalTrials.gov ID: NCT05402072
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- Focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on MRI and confirmed on arthroscopic examination
- Patient agrees to participate in the study-specific postoperative rehabilitation protocol
You likely can't join if
- 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
- Known hypersensitivity or allergy to porcine collagen
- Acute or chronic infection at the surgical site
See the full eligibility criteria
- 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
- Patient agrees to participate in the study-specific postoperative rehabilitation protocol
- Patient can speak, read, and understand the language of the site
- Patient has provided informed consent
- 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
- Known hypersensitivity or allergy to porcine collagen
- Acute or chronic infection at the surgical site
- Evidence of hip dysplasia (i.e., lateral centre edge angle \< 20˚)
- Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
- Immunosuppressive or anti-proliferative medication use
- Chronic pain syndromes
- Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
- History of paediatric hip disease
- Uncontrolled diabetes
- Contraindications to MRI imaging (e.g. claustrophobia)
- Patient is involved in ongoing legal or workplace claims
- Patient is incarcerated
- Patient is pregnant or breastfeeding
- Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
- Any other reason(s) the investigator feels is relevant for excluding the patient
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.