CompletedNCT02022930Updated Aug 25, 2016

Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

A Phase 3 interventional study of Hydros and Hydros-TA in Osteoarthritis of the Knee, sponsored by Carbylan Therapeutics, Inc.. Completed at 5 sites in 3 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-08-25.

Sponsored by Carbylan Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 510
Allocation: Randomized
Ages: 40 Years to 85 Years
Sex: All

Study summary

The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.

Conditions studied

Osteoarthritis of the Knee

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Keywords

Osteoarthritis
Knee

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 510 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Carbylan Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
Symptoms in the index knee for at least 12 months.
Fully ambulatory Subject (ability to perform a 15 meters walk test).
Male and female Subjects 40 through 85 years of age.

Exclusion criteria

Exclusion Criteria:

BMI >40 kg
Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
Intra articular steroid therapy in last 3 months
Intra articular viscosupplementation in last 6 months

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 510 participants (estimated)

Study arms

Experimental
Hydros
Hydros Joint Therapy
Device: Hydros
Experimental
Hydros-TA
Hydros-TA Joint Therapy
Device: Hydros-TA
Active comparator
Triamcinolone acetonide
Triamcinolone acetonide
Drug: Triamcinolone Acetonide

Interventions

DeviceHydros
DeviceHydros-TA
DrugTriamcinolone Acetonide

What researchers measure

Primary outcomes

Change from baseline in the WOMAC A subscale score for the treatment knee.
Time frame: 2 weeks and 26 weeks

Secondary outcomes

Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
Time frame: 26 weeks

Study locations

5 sites

St.Leonards, New South Wales, Australia
London, Ontario, Canada
Oshawa, Canada
Quebec City, Canada
Willemstad, Curacao, Netherlands Antilles

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02022930
Lead sponsor: Carbylan Therapeutics, Inc.
Responsible party: Sponsor
First posted: Dec 30, 2013
Start date: Jan 2014
Primary completion: Dec 2015
Completion: Jun 2016
Last update: Aug 25, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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