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Intraarticular Xylitol Injections for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Xylitol
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylitol injection

Control

Arm Description

Intraarticular injection of Xylitol

Outcomes

Primary Outcome Measures

Pain - visual analogue scale

Secondary Outcome Measures

Full Information

First Posted
April 2, 2014
Last Updated
April 16, 2014
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02104596
Brief Title
Intraarticular Xylitol Injections for Knee Osteoarthritis
Official Title
Intraarticular Xylitol Injections for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylitol injection
Arm Type
Experimental
Arm Description
Intraarticular injection of Xylitol
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Xylitol
Primary Outcome Measure Information:
Title
Pain - visual analogue scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonid Kandel, MD
Phone
+97225844500
Email
kandel@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg
Phone
00 972 2 6776095
Email
lhadas@hadassah.org.il

12. IPD Sharing Statement

Learn more about this trial

Intraarticular Xylitol Injections for Knee Osteoarthritis

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