Prospective Single Center Open Label Study of Shoulder OA Pain

NCT02610504 | Completed

• 1 other identifier: 13DUR503
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients

Conditions

Osteoarthritis

Keywords

degenerative arthritis

Outcome Measures

Primary Outcomes (1)

• Shoulder pain on movement (SPOM) 0-100mm VAS

  over 26 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

Durolane 3ml

EXPERIMENTAL

Single intra-articular injection into shoulder

Device: Durolane

Interventions

Durolane DEVICE

single injection of 3ml

Also known as: Hyaluronic Acid

Durolane 3ml

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bioventus LLC: lead

Study Sites (1)

St. Michaels Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael McKee, MD

  St. Michaels Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: April 8, 2015
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)