High Tibial Osteotomy (HTO) With or Without Arthroscopy o... | NCT01614288

Studies
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint

NCT01614288

Sponsor

University of Western Ontario, Canada

Status

Withdrawn

Last Update Posted

Feb 8, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Medial Compartment Osteoarthritis of the Knee

Interventions

knee Arthroscopy
No arthroscopy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 4, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knee Arthroscopy + HTO	Active Comparator		Procedure: knee Arthroscopy
HTO Alone	Active Comparator		Other: No arthroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
knee Arthroscopy	Procedure	Patient undergoes a knee arthroscopy and HTO	Knee Arthroscopy + HTO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOMAC		Preoperatively; 3, 6, 12, 18 and 24 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dianne Bryant, PhD	The University of Western Ontario	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre - University Hospital		London	Ontario		Canada