Intraarticular Xylitol Injections for Knee Osteoarthritis

NCT ID: NCT02104596

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Brief Summary

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Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xylitol injection

Intraarticular injection of Xylitol

Group Type EXPERIMENTAL

Xylitol

Intervention Type DEVICE

Control

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Xylitol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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KANDEL

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Leonid Kandel, MD

Role: CONTACT

+97225844500

Facility Contacts

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Hadas Lemberg

Role: primary

00 972 2 6776095

Other Identifiers

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Xylitol- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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