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The MONOVISC Hip Osteoarthritis Study

NCT02698865 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-12-01

Study results available
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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).

Conditions

  • Osteoarthritis of the Hip

Interventions

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)

Sponsors & Collaborators

  • DePuy Mitek

    lead INDUSTRY

Principal Investigators

  • Brooks J Story, PhD · DePuy Synthes Mitek Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2019-03-15
Completion
2019-06-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698865 on ClinicalTrials.gov