Intraarticular Xylitol Injections for Knee Osteoarthritis

April 16, 2014 updated by: KANDEL, Hadassah Medical Organization
Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 45
  • Tibiofemoral osteoarthritis
  • OA stage 2-3 on xray
  • Pain VAS > 40mm
  • No NSAIDs for 3 weeks
  • No analgetics for 38 hours

Exclusion Criteria:

  • Pain VAS > 80mm
  • Pain VAS in contralateral knee > 40mm
  • Inflammatory arthritis
  • Severe effusion
  • Posttraumatic osteoarthritis
  • Unstable knee
  • Isolated patellofemoral disease
  • Paracetamol hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
EXPERIMENTAL: Xylitol injection
Intraarticular injection of Xylitol
Device: Xylitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain - visual analogue scale
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (ESTIMATE)

April 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xylitol- HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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