Prospective Single Center Open Label Study of Shoulder OA Pain

B

Bioventus

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Durolane

Study type

Interventional

Funder types

Industry

Identifiers

NCT02610504
13DUR503

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

Durolane 3ml
Experimental group
Description:
Single intra-articular injection into shoulder
Treatment:
Device: Durolane

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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