NCT02698865

The MONOVISC Hip Osteoarthritis Study

A Pivotal Study Comparing Two Injections of MONOVISC to Two Injections of Saline in Patients With Osteoarthritis of the Hip

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: DePuy Mitek · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine the effectiveness of MONOVISC for the relief of pain and symptoms of osteoarthritis of the hip. Specifically, the study will determine if MONOVISC is more effective than a placebo treatment when delivered as intra-articular injections (injected directly into the hip joint). In this case, the placebo will be a dilute solution of salt water (saline).

Detailed description

The primary objective of this study is determine whether two intra-articular injections of MONOVISC, separated by 1 month, are superior to two intra-articular injections of physiologic saline, separated by 1 month, in relieving hip osteoarthritis pain, as determined by reduction in walking pain change from baseline.

Conditions

• Osteoarthritis of the Hip

Interventions

Type	Name	Description
DEVICE	MONOVISC	Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
DEVICE	Saline	Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-03-15
• Completion: 2019-06-24
• First posted: 2016-03-04
• Last updated: 2021-12-01
• Results posted: 2020-03-04

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study