Femoroacetabular ImpingementCHASENCT04875767
Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Bone Marrow Aspirate Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
A study testing HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) in people with Femoroacetabular Impingement and Cartilage Damage, run by McMaster University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Femoroacetabular Impingement, Cartilage Damage
- What is being tested?
- HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2023to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 18-40 years
- Hip pain lasting 6 months or more with no relief from documented non-operative modalities
- Cam, Pincer, or Mixed FAI
- 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 1x1 cm2 and 5x5 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
Who cannot join
- 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 2 or 3)
- Known hypersensitivity or allergy to hyaluronate
- Evidence of hip dysplasia (i.e. lateral centre edge angle < 20˚)
Show all 16Show fewer
- 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 who will likely have problems, in the judgement of the investigator, with maintaining follow-up
About this study
Official title: 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
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
- Being tested
- HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) | Experimental | Those allocated to the scaffold treatment group will have 30 ml of BMA harvested from the ipsilateral iliac crest under fluoroscopic guidance. The hip arthroscopy will then be resumed, and the damaged cartilage lesion will be debrided using a mechanical shaver to remove loose and calcified tissue. Once the walls of the lesion are confirmed to be stable with a probe, the exact size of the defect will be measured for templating of the scaffold. The biodegradable HA-based scaffold (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) will be prepared by cutting it to fit the focal defect. Once the cartilage lesion is dried manually, this scaffold will be implanted into the defect after it has been soaked in the BMA. The scaffold will then be secured to the defect in a press-fit fashion to the surrounding cartilage. In the case where additional fixation of the scaffold is needed, such as uncontained shoulder of cartilage, fibrin glue will be used to secure the scaffold. Receives: Device: HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) |
| Microfracture | Active comparator | As per current standard of care for focal articular cartilage lesions of the acetabulum, the unstable cartilage will be debrided and removed from the subchondral bone using a mechanical shaver until a stable margin is obtained. A ring curette will be used to remove the calcified cartilage layer and create a border of healthy cartilage tissue that can support the marrow clot. Through the mid-anterior portal, specialized 90˚ awls will then be placed with the tip perpendicular to the subchondral bone of the acetabulum, and a mallet will be used to penetrate the subchondral bone with perforations 3 mm deep to access the bone marrow elements. This is done until the defect is homogeneously covered with micro-perforations 2-3 mm apart. Receives: Device: HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Hip Outcome Tool-33 (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 questionnaire has been validated in this patient population and has demonstrated efficacy, reliability, and responsiveness to change.
Measured: 24 months
Secondary outcomes (4)
Visual Analogue Scale (100-point scale) (VAS)
The VAS is one of the most frequently used pain rating scales in clinical practice and research. The VAS is a validated unidimensional scale that is easy to use, requires no verbal or reading skills, and is sufficiently versatile to be employed in a variety of settings.
Measured: 24 months
Euro-Qol 5-D (EQ-5D)
The EQ-5D is a standardized, utility-based instrument for use as a measure of health outcome. It comprises 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression. The EQ-5D has been used in previous studies involving patients with hip pain and has been extensively validated.
Measured: 24 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
The MOCART scale has been validated to demonstrate the extent of cartilage restoration following surgical repair, examining factors such as "degree of defect repair and filling of the defect", and "integration to border zone". The MOCART scale is applied to MRIs.
Measured: 24 months
Adverse events
Reported complications such as infection, additional or revision surgery, hypersensitivity or allergic reactions, reduced range of motion, and any other adverse events.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start3 Jan 2023
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Why it stopped: Funding restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875767
- Sponsor's protocol ID
- CHASE01
- Acronym
- CHASE
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04875767
- Acronym / sponsor ID
- CHASE / CHASE01
- Conditions
- Femoroacetabular Impingement, Cartilage Damage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) | Experimental | Device: HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)Those allocated to the scaffold treatment group will have 30 ml of BMA harvested from the ipsilateral iliac crest under fluoroscopic guidance. The hip arthroscopy will then be resumed, and the damaged cartilage lesion will be debrided using a mechanical shaver to remove loose and calcified tissue. Once the walls of the lesion are confirmed to be stable with a probe, the exact size of the defect will be measured for templating of the scaffold. The biodegradable HA-based scaffold (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) will be prepared by cutting it to fit the focal defect. Once the cartilage lesion is dried manually, this scaffold will be implanted into the defect after it has been soaked in the BMA. The scaffold will then be secured to the defect in a press-fit fashion to the surrounding cartilage. In the case where additional fixation of the scaffold is needed, such as uncontained shoulder of cartilage, fibrin glue will be used to secure the scaffold. |
| Microfracture | Active comparator | Device: HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)As per current standard of care for focal articular cartilage lesions of the acetabulum, the unstable cartilage will be debrided and removed from the subchondral bone using a mechanical shaver until a stable margin is obtained. A ring curette will be used to remove the calcified cartilage layer and create a border of healthy cartilage tissue that can support the marrow clot. Through the mid-anterior portal, specialized 90˚ awls will then be placed with the tip perpendicular to the subchondral bone of the acetabulum, and a mallet will be used to penetrate the subchondral bone with perforations 3 mm deep to access the bone marrow elements. This is done until the defect is homogeneously covered with micro-perforations 2-3 mm apart. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female patients aged 18-40 years
- Hip pain lasting 6 months or more with no relief from documented non-operative modalities
- Cam, Pincer, or Mixed FAI
- 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 1x1 cm2 and 5x5 cm2 on MRI and confirmed on arthroscopic examination
Key exclusion criteria (16 listed)
- 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 2 or 3)
- Known hypersensitivity or allergy to hyaluronate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA), Microfracture |
Primary outcome
International Hip Outcome Tool-33 (iHOT-33)
Time frame: 24 months
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 questionnaire has been validated in this patient population and has demonstrated efficacy, reliability, and responsiveness to change.
4 secondary outcomes
Visual Analogue Scale (100-point scale) (VAS)
Time frame: 24 months
Euro-Qol 5-D (EQ-5D)
Time frame: 24 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)
Time frame: 24 months
Adverse events
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Femoroacetabular Impingement
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA) in people with Femoroacetabular Impingement and Cartilage Damage, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Hip Outcome Tool-33 (iHOT-33) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.