Hip OsteoarthritisECHONCT04084704
A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis
A study testing Cingal in people with Hip Osteoarthritis, run by McMaster University at 1 site in Canada.
Trial summary
Osteoarthritis (OA) of the hip is one of the ten most disabling diseases in the developed world. Because OA gradually worsens over time, the sooner treatment is started, the more likely its impact is lessened. Hip OA is characterized by joint pain, cartilage degeneration, and an increase in disability. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Cingal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 7 Jun 2023
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women ages 40 to 65 years
- Hip OA (mild to moderate) diagnosed on x-ray and/or MRI (Tonnis grade 1 and 2)
- Patient is using only nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen/ paracetamol (Tylenol) for pain relief during the month before receiving Cingal
- Patient is willing to stop pain/anti-inflammatory medication at least two weeks prior to receiving Cingal through the end of the study (6 months)
- Patient speaks, reads, and understands the language of the clinical site
- Provision of informed consent
Who cannot join
- Evidence of hip dysplasia (centre edge angle less than 20 degrees)
- Presence of advanced hip OA (Tonnis Grade 3)
- Previous trauma to the affected hip requiring medical or surgical treatment
- Previous surgery on the affected hip or contralateral hip
- Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
- Infections or skin diseases at target hip joint
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- Immunosuppressive medication use
- Chronic pain syndromes
- Significant medical co-morbidities (requiring daily assistance for activities of daily living)
- History of paediatric hip disease (e.g. Legg-Calve-Perthes; slipped capital femoral epiphysis)
- Previous cartilage repair procedure (microfracture, Osteochondral Autograft Transplantation System (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index hip)
- Known hypersensitivity (allergy) to hyaluronan preparations
- Known hypersensitivity (allergy) to triamcinolone hexacetonide preparations
- Known sensitivity to any of the materials in Cingal
- Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned
- HA intra-articular injections into the index hip within the last 6 months before receiving Cingal
- Corticosteroid therapy by systemic, intra-articular, or intramuscular route or oral corticosteroids within the last 6 months before receiving Cingal
- Any injection received in the hip prior to receiving or received concurrently with Cingal
- Uncontrolled diabetes
- Subject is a woman who is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study
- Patient is incarcerated
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Rheumatoid arthritis or gouty arthritis
- Current diagnosis of osteomyelitis
- Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
- Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin or anti-platelet agents [e.g. ASA, Plavix]) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
- Participation in concurrent trial that involves a medical intervention
- Patient is currently receiving workman's compensation or disability, has been involved in an motor vehicle accident, or is in litigation for workman's compensation or disability claims
- Likely problems, in the judgment of the treating physician, with maintaining follow up (e.g. patients with no fixed address, plans to move out of town). This may include patients with severe mental disorders and drug addictions without adequate support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (ECHO Study)
Osteoarthritis (OA) of the hip is one of the ten most disabling diseases in the developed world. Because OA gradually worsens over time, the sooner treatment is started, the more likely its impact is lessened. Hip OA is characterized by joint pain, cartilage degeneration, and an increase in disability. Multiple treatments are used to manage the degenerating hip as well as the associated pain. These include physiotherapy and rehabilitation, bracing, other walking aids, oral medications, injections, and in severe cases, surgery. Prior research has shown that injection of hyaluronic acid (HA) and corticosteroids can slow down OA degradation. This study will look at the effects of injecting Cingal into the hip, which expands on its current approved use in the treatment of knee OA.
- Conditions
- Hip Osteoarthritis
- Being tested
- Cingal
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CingalDevice
Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Cingal injection | Other | Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic. Receives: Device: Cingal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported hip pain as measured by Visual Analog Scale
The primary objective of this observational study is to determine, among individuals with hip OA ages 40-65 years, the effect of Cingal on patient-reported hip pain, as measured by a Visual Analogue Scale (VAS), at 6-months post-injection.
Measured: 6 months
Secondary outcomes (5)
Hip Function, as measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS)
The HOOS was designed to assess patient opinions about their hip and associated problems in an adult population with a hip disability with or without OA. The HOOS has been extensively validated and consists of 5 subscales for pain, other symptoms, function in activities of daily living, function in sports and recreation, and hip-related quality of life.
Measured: 6 months
Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12)
The SF-12 may be self or interview-administered and can help document mental and physical components of quality of life. Points can range from 0-100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Measured: 6 months
Physical activity levels as measured by a wrist-worn activity tracker
To be worn for one week prior to each follow-up visit.
Measured: 6 months
Complications, including infection and other adverse events at 6-months post-injection.
Adverse events
Measured: 6 months
Range of motion
ROM will be measured with standard anterior and posterior impingement tests, the log roll test, and hip flexion/extension, abduction/adduction, and internal/external rotation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Sep 2020
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Anika Therapeutics, Inc.
- Responsible party
- Principal investigator, Olufemi Ayeni, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084704
- Sponsor's protocol ID
- 7692
- Acronym
- ECHO
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (ECHO Study)
- ClinicalTrials.gov ID
- NCT04084704
- Acronym / sponsor ID
- ECHO / 7692
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Anika Therapeutics, Inc.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 10 Sep 2019 (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.
Osteoarthritis (OA) of the hip is one of the ten most disabling diseases in the developed world. Because OA gradually worsens over time, the sooner treatment is started, the more likely its impact is lessened. Hip OA is characterized by joint pain, cartilage degeneration, and an increase in disability. Multiple treatments are used to manage the degenerating hip as well as the associated pain. These include physiotherapy and rehabilitation, bracing, other walking aids, oral medications, injections, and in severe cases, surgery. Prior research has shown that injection of hyaluronic acid (HA) and corticosteroids can slow down OA degradation. This study will look at the effects of injecting Cingal into the hip, which expands on its current approved use in the treatment of knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cingal injection | Other | Device: CingalCingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult men or women ages 40 to 65 years
- Hip OA (mild to moderate) diagnosed on x-ray and/or MRI (Tonnis grade 1 and 2)
- Patient is using only nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen/ paracetamol (Tylenol) for pain relief during the month before receiving Cingal
- Patient is willing to stop pain/anti-inflammatory medication at least two weeks prior to receiving Cingal through the end of the study (6 months)
- Patient speaks, reads, and understands the language of the clinical site
Key exclusion criteria (29 listed)
- Evidence of hip dysplasia (centre edge angle less than 20 degrees)
- Presence of advanced hip OA (Tonnis Grade 3)
- Previous trauma to the affected hip requiring medical or surgical treatment
- Previous surgery on the affected hip or contralateral hip
- Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
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 |
|---|---|---|
| CingalCingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic. | Device | Cingal injection |
Primary outcome
Patient reported hip pain as measured by Visual Analog Scale
Time frame: 6 months
The primary objective of this observational study is to determine, among individuals with hip OA ages 40-65 years, the effect of Cingal on patient-reported hip pain, as measured by a Visual Analogue Scale (VAS), at 6-months post-injection.
5 secondary outcomes
Hip Function, as measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 6 months
Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12)
Time frame: 6 months
Physical activity levels as measured by a wrist-worn activity tracker
Time frame: 6 months
Complications, including infection and other adverse events at 6-months post-injection.
Time frame: 6 months
Range of motion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cingal in people with Hip Osteoarthritis, run by McMaster University at 1 site in Canada.
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 6 inclusion and 29 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient reported hip pain as measured by Visual Analog Scale (time frame: 6 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 Sep 2023.