NCT04640961

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint

A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the shoulder joint.

Detailed description

Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). Participants to be followed to 6 Months post-injection.

Conditions

• Osteoarthritis, Shoulder

Interventions

Type	Name	Description
DEVICE	Cingal	Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH).

Timeline

• Start date: 2021-01-16
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2020-11-23
• Last updated: 2024-12-16
• Results posted: 2024-03-07

Locations

4 sites across 2 countries: Czechia, Poland