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Intraarticular Xylitol Injections for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02104596
Recruitment Status : Unknown
Verified April 2014 by KANDEL, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
KANDEL, Hadassah Medical Organization

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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Xylitol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraarticular Xylitol Injections for Knee Osteoarthritis
Study Start Date : May 2014
Estimated Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Xylitol

Arm Intervention/treatment
Experimental: Xylitol injection
Intraarticular injection of Xylitol
Device: Xylitol
Placebo Comparator: Control



Primary Outcome Measures :
  1. Pain - visual analogue scale [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104596


Contacts
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Contact: Leonid Kandel, MD +97225844500 kandel@hadassah.org.il

Locations
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Israel
Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg    00 972 2 6776095    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization

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Responsible Party: KANDEL, Orthopedic Surgeon, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02104596     History of Changes
Other Study ID Numbers: Xylitol- HMO-CTIL
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases