OsteoarthritisNCT02610504
Prospective Single Center Open Label Study of Shoulder OA Pain
A study testing Durolane in people with Osteoarthritis, run by Bioventus LLC at 1 site in Canada.
Trial summary
Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Durolane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2015to 23 May 2017
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of glenohumeral osteoarthritis
- SPOM score greater than or equal to 50 in study shoulder
- Willing to discontinue oral and topical analgesia other than rescue acetaminophen
- abstinence from any other IA or per-articular injections for the shoulder during the course of the trial
- patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month
- pain at least 50% of the days during previous month
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- patients who have failed conventional therapy of NSAIDs or steroid injections
- patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder
- cooperative and able to communicate effectively
- agree not to participate in any other studies during trial
Who cannot join
- significant pain from other joints requiring chronic analgesic therapy
- presence of one or more conditions besides OA that could confound pain and functional assessments
- clinically apparent tense effusion, malalignment or instability in study shoulder
- shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity
- inability to abstain from analgesic use other than rescue acetaminophen
- IA injections of steroids to the study shoulder within 3 months or any other joint within the prior month
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- IA injection of hyaluronic acid in the study shoulder within 9 months of baseline
- allergic reaction to HA
- any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder
- uncontrolled hypothyroidism
- pregnant or breastfeeding women
- planned surgical procedure
- history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site
- treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 26 Week Prospective Open Label Clinical Study Evaluating A Single Intra-Articular Injection of Durolane 3ml for Treatment of Osteoarthritis Pain of the Shoulder
Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients
Read the detailed description
Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.
- Conditions
- Osteoarthritis
- Being tested
- Durolane
- Keywords
- degenerative arthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurolaneDevice
Also called Hyaluronic Acid
single injection of 3ml
| Study group | Role | What they receive |
|---|---|---|
| Durolane 3ml | Experimental | Single intra-articular injection into shoulder Receives: Device: Durolane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain on movement (SPOM) 0-100mm VAS
Measured: over 26 weeks
Secondary outcomes (5)
Shoulder pain at night (SPAN) 0-100mm VAS
Measured: over 26 weeks
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form
Measured: over 26 weeks
Patient Global Assessment (PGA)
Measured: over 26 weeks
Shoulder pain rescue medication diary
Measured: over 26 weeks
Adverse events, concomitant medications, physical exam
Measured: over 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start8 Apr 2015
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McKee, MD, Principal investigator, St. Michaels Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610504
- Sponsor's protocol ID
- 13DUR503
- Status last verified
- Feb 2021
- First submitted
- 18 Nov 2015
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26 Week Prospective Open Label Clinical Study Evaluating A Single Intra-Articular Injection of Durolane 3ml for Treatment of Osteoarthritis Pain of the Shoulder
- ClinicalTrials.gov ID
- NCT02610504
- Acronym / sponsor ID
- 13DUR503
- Conditions
- Osteoarthritis
- Keywords
- degenerative arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients
Detailed description
Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durolane 3ml | Experimental | Device: DurolaneSingle intra-articular injection into shoulder |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of glenohumeral osteoarthritis
- SPOM score greater than or equal to 50 in study shoulder
- Willing to discontinue oral and topical analgesia other than rescue acetaminophen
- abstinence from any other IA or per-articular injections for the shoulder during the course of the trial
- patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month
Key exclusion criteria (14 listed)
- significant pain from other joints requiring chronic analgesic therapy
- presence of one or more conditions besides OA that could confound pain and functional assessments
- clinically apparent tense effusion, malalignment or instability in study shoulder
- shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity
- inability to abstain from analgesic use other than rescue acetaminophen
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 |
|---|---|---|
| DurolaneAlso: Hyaluronic Acidsingle injection of 3ml | Device | Durolane 3ml |
Primary outcome
Shoulder pain on movement (SPOM) 0-100mm VAS
Time frame: over 26 weeks
5 secondary outcomes
Shoulder pain at night (SPAN) 0-100mm VAS
Time frame: over 26 weeks
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form
Time frame: over 26 weeks
Patient Global Assessment (PGA)
Time frame: over 26 weeks
Shoulder pain rescue medication diary
Time frame: over 26 weeks
Adverse events, concomitant medications, physical exam
Time frame: over 26 weeks
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 16 Feb 2021.
- Individual participant dataSharing planned: No
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Single vs Triple Hyaluronic Acid in Knee 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.
Michael McKee, MD principal investigator
St. Michaels Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Durolane in people with Osteoarthritis, run by Bioventus LLC 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 10 inclusion and 14 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 16 Feb 2021. 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?
Shoulder pain on movement (SPOM) 0-100mm VAS (time frame: over 26 weeks). 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 16 Feb 2021.