Phase 3 N=274 Randomized Double-blind Treatment

ORTHOVISC Shoulder Osteoarthritis Study

Glenohumeral Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00436969 ↗

Enrolled (actual)

274

Serious AEs

4.8%

Results posted

Apr 2014

Primary outcome: Primary: Visual Analog Scale (VAS) Pain Score (Per Protocol) — 30.389; 28.917 mm on a 100 mm VAS scale — p=0.696

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Orthovisc (Device); Control (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: DePuy Mitek
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Scale (VAS) Pain Score (Per Protocol)	30.389; 28.917	0.696
PRIMARY Visual Analog Scale (VAS) Pain Score (As Treated)	33.196; 30.406	0.410
SECONDARY Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)	63.8; 63.6	—
SECONDARY Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)	59.7; 54.4	—
SECONDARY Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)	-23.624; -24.494	0.827
SECONDARY Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)	-16.882; -19.756	0.392
SECONDARY American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)	18.329; 17.397	0.772
SECONDARY American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)	12.960; 13.988	0.707
SECONDARY American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)	18.228; 17.408	0.790
SECONDARY American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)	14.272; 15.402	0.685
SECONDARY Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)	-17.871; -10.554	0.018 sig
SECONDARY Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)	-11.828; -9.467	0.369
SECONDARY Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)	-16.109; -13.492	0.379
SECONDARY Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)	-10.314; -12.522	0.409
SECONDARY 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)	3.607; 2.050	0.232
SECONDARY 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)	2.179; 1.950	0.832
SECONDARY 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)	2.763; 2.831	0.957
SECONDARY 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)	1.559; 2.779	0.267
SECONDARY 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)	-0.130; 1.060	0.333
SECONDARY 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)	0.167; 0.938	0.473
SECONDARY 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)	0.397; 0.379	0.988
SECONDARY 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)	0.330; 0.798	0.671

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00436969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.