Prospective Single Center Open Label Study of Shoulder OA Pain

NCT ID: NCT02610504

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-08
• Study Completion Date: 2017-05-23

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Durolane 3ml

Single intra-articular injection into shoulder

Group Type: EXPERIMENTAL

Durolane

Intervention Type: DEVICE

single injection of 3ml

Interventions

Durolane

single injection of 3ml

Intervention Type: DEVICE

Other Intervention Names

Hyaluronic Acid

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioventus LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael McKee, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michaels Hospital

Locations

St. Michaels Hospital

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

13DUR503

Identifier Type: -

Identifier Source: org_study_id