Clinical trial NCT02610504: Prospective Single Center Open Label Study of Shoulder OA Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: degenerative arthritis
Lead sponsor: Bioventus LLC
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Shoulder pain on movement (SPOM) 0-100mm VAS
timeFrame: over 26 weeks
Secondary outcomes:
measure: Shoulder pain at night (SPAN) 0-100mm VAS
timeFrame: over 26 weeks
measure: American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form
timeFrame: over 26 weeks
measure: Patient Global Assessment (PGA)
timeFrame: over 26 weeks
measure: Shoulder pain rescue medication diary
timeFrame: over 26 weeks
measure: Adverse events, concomitant medications, physical exam
timeFrame: over 26 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
Study officials:
affiliation: St. Michaels Hospital
name: Michael McKee, MD
role: PRINCIPAL_INVESTIGATOR
References: