Prospective Single Center Open Label Study of Shoulder OA Pain

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610504
• Other study ID #: 13DUR503
• Status: Completed
• Phase: N/A
• Start date: April 8, 2015
• Est. completion date: May 23, 2017

Study information

• Verified date: February 2021
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Durolane
single injection of 3ml

Locations

Country	Name	City	State
Canada	St. Michaels Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Bioventus LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain on movement (SPOM) 0-100mm VAS		over 26 weeks
Secondary	Shoulder pain at night (SPAN) 0-100mm VAS		over 26 weeks
Secondary	American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form		over 26 weeks
Secondary	Patient Global Assessment (PGA)		over 26 weeks
Secondary	Shoulder pain rescue medication diary		over 26 weeks
Secondary	Adverse events, concomitant medications, physical exam		over 26 weeks