ORTHOVISC Shoulder Osteoarthritis Study

NCT00436969 | Completed Phase 3 Results DMC

• 1 other identifier: 06-OV-01
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 13

Brief Summary

A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

Conditions

Glenohumeral Osteoarthritis

Keywords

Orthovisc; Osteoarthritis; Shoulder; Randomized

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) Pain Score (Per Protocol)

  Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

  6 Months

• Visual Analog Scale (VAS) Pain Score (As Treated)

  Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

  6 Months

Secondary Outcomes (20)

• Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)

  Baseline and 6 months

• Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)

  Baseline and 6 months

• Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)

  Baseline and 12 weeks

• Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)

  Baseline and 12 weeks

• American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)

  Baseline and 12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).

Drug: Control

Investigational

EXPERIMENTAL

Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.

Device: Orthovisc

Interventions

Orthovisc DEVICE

Orthovisc injection

Also known as: Hyaluronic acid

Investigational

Control DRUG

Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Also known as: Corticosteroid

Control

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A candidate for unilateral treatment of osteoarthritis of the shoulder
• Have failed conservative treatment

You may not qualify if:

• Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
• No active instability or acute dislocation episodes within the previous 12 months
• Known allergy to hyaluronate preparations
• Pregnant or breast feeding
• Is receiving prescription pain medication for conditions unrelated to the index shoulder condition

Sponsors & Collaborators

• DePuy Mitek: lead

Study Sites (13)

CORE Orthopedics

Encinitas, California, 92024, United States

Location

Sierra Pacific Orthopaedic Center Medical Group

Fresno, California, 93720, United States

Location

UHZ Sports Medicine

Coral Gables, Florida, 33146, United States

Location

Andrews Research Institute

Gulf Breeze, Florida, 32561, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Massachusetts Merdical School - Worcester

Worcester, Massachusetts, 01605, United States

Location

Shores Rheumatology

Saint Clair Shores, Michigan, 48081, United States

Location

Insall Scott Kelly Institute

New York, New York, 10065, United States

Location

Tulsa Bone and Joint

Tulsa, Oklahoma, 74146, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

The Methodist

Houston, Texas, 11030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Aileen Michael
• Organization: DePuy Mitek

amichae2@its.jnj.com

508.828.3337

Study Officials

• Jonathan B. McGlohorn

  DePuy Synthes Mitek and Biomaterials

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: December 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2011
• Last Updated: March 9, 2017
• Results First Posted: April 11, 2014

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)