NCT04875767

Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Bone Marrow Aspirate Compared With Microfracture for Focal Articular Cartilage Damage of the Hip

Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Bone Marrow Aspirate Compared With Microfracture for Focal Articular Cartilage Damage of the Hip: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Femoroacetabular impingement (FAI) is a hip disorder resulting from a mismatch of the hip joint, resulting in hip pain and can potentially cause osteoarthritis. As the head of the femur (ball of the hip) and the acetabulum (socket of the hip) impinge or rub together with this mismatch, patients can suffer damage to their articular cartilage which covers both. Currently, the standard of care to surgically treat articular cartilage damage is a procedure called 'microfracture' - where the surgeon makes multiple holes in the bone under the defects causing bone marrow cells and blood from the holes to combine to form a "super clot" that covers the damaged area and is meant to be the basis for new tissue formation or 'fibrocartilage'. However, native articular cartilage is made of hyaline, rather than fibrocartilage, which is a more flexible and durable tissue able to withstand a great deal of force on the hip when it moves. Therefore, a more recently developed strategy that has gained popularity for use in the repair of articular cartilage in the knee involves the implantation of bone marrow aspirate (BMA) along with a scaffold made of hyaluronic acid (HA) in a single-step procedure, with the goal of promoting new hyaline-like tissue. While this has shown promising results in treating knee cartilage damage, this treatment method has yet to be studied in the hip. This randomized controlled trial will evaluate in patients with painful articular cartilage damage of the hip, the effect of implantation of an HA scaffold along with BMA in comparison to microfracture on hip pain and function, cartilage regeneration, and any complications at 24 months post-surgery.

Conditions

• Femoroacetabular Impingement
• Cartilage Damage

Interventions

Type	Name	Description
DEVICE	HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)	General surgical and anaesthetic risks apply to the subjects included in the trial. Microfracture and BMA are surgical techniques currently being used and are approved for use in Canada. The HA-scaffold that will be used in this trial (Hyalofast®, Anika Therapeutics Inc.) has European CE Mark for use in all joints. We will obtain a Health Canada approval to use the Hyalofast® product in the hip for this trial.

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-11-19
• Completion: 2024-11-19
• First posted: 2021-05-06
• Last updated: 2024-11-21