NCT01614288

Brief Summary

Participants will be randomized to undergo a High Tibial Osteotomy (HTO) with or without a knee scope. Patients will be tested in the Gait Lab, will fill out quality-of-life questionnaires, and have a clinical evaluation done preoperative and at each follow-up visit.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

First QC Date

June 4, 2012

Last Update Submit

February 6, 2013

Conditions

Medial Compartment Osteoarthritis of the Knee

Keywords

HTOArthroscopyQuality-of-LifeGait Analysis

Outcome Measures

Primary Outcomes (1)

  • WOMAC

    Preoperatively; 3, 6, 12, 18 and 24 months

Secondary Outcomes (4)

  • The Lower Extremity Functional Scale (LEFS)

    Preoperatively; 3, 6, 12, 18 and 24 months

  • Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.

    Daily x 2 weeks post surgery; Weekly x 3 months

  • SF-12

    Preoperatively; 3, 6, 12, 18 and 24 months

  • Gait Testing Procedures

    6, 12 and 24 months post-operatively

Study Arms (2)

Knee Arthroscopy + HTO

ACTIVE COMPARATOR
Procedure: knee Arthroscopy

HTO Alone

ACTIVE COMPARATOR
Other: No arthroscopy

Interventions

knee ArthroscopyPROCEDURE

Patient undergoes a knee arthroscopy and HTO

Knee Arthroscopy + HTO
No arthroscopyOTHER

Patient undergoes an HTO without knee arthroscopy

HTO Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients booked for an HTO due to OA
  • Grades II to IV severity of OA by radiographic evaluation (Kellgren \& Lawrence grade)
  • OA of the knee primarily involving the medial compartment

You may not qualify if:

  • Imaging evidence of significant knee joint pathology that would change the decision to do an HTO
  • An arthroscopy of the knee within 2 years of planned surgery
  • Active joint or systemic infection,
  • Major medical illness that would preclude undergoing surgery,
  • Patients who are unwilling or unable to be assessed according to study protocol for two years following surgery
  • Major psychiatric illness, developmental handicap or inability to read and understand the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Location

Study Officials

  • Dianne Bryant, PhD

    The University of Western Ontario

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 7, 2012

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

CA(1)