NCT02104596

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

April 2, 2014

Last Update Submit

April 16, 2014

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain - visual analogue scale

    3 months

Study Arms (2)

Xylitol injection

EXPERIMENTAL

Intraarticular injection of Xylitol

Device: Xylitol

Control

PLACEBO COMPARATOR

Interventions

XylitolDEVICE
Xylitol injection

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Leonid Kandel, MD

CONTACT

+97225844500kandel@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

IL(1)