Prospective Single Center Open Label Study of Shoulder OA Pain

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Durolane

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • St. Michaels Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Durolane 3ml; Single intra-articular injection into shoulder	Device: Durolane; single injection of 3ml; Other Names: Hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Shoulder pain on movement (SPOM) 0-100mm VAS	over 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Shoulder pain at night (SPAN) 0-100mm VAS	over 26 weeks
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form	over 26 weeks
Patient Global Assessment (PGA)	over 26 weeks
Shoulder pain rescue medication diary	over 26 weeks
Adverse events, concomitant medications, physical exam	over 26 weeks

Collaborators and Investigators

• Sponsor: Bioventus LLC
• Investigators: Principal Investigator: Michael McKee, MD, St. Michaels Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2015
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): May 23, 2017

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: degenerative arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 13DUR503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No