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

Medial Compartment Osteoarthritis of the Knee Clinical Trial

Official title:

A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint on Quality of Life, Function, Pain and Swelling for Patients With Medical Compartment Osteoarthritis of the Knee

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01614288
• Other study ID #: FKSMC 2010 - 2
• Status: Withdrawn
• Phase: N/A
• First received: June 4, 2012
• Last updated: February 6, 2013

Study information

• Verified date: February 2013
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Reveiw Board, The University of Western Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medial Compartment Osteoarthritis of the Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• knee Arthroscopy
Patient undergoes a knee arthroscopy and HTO

Other:
• No arthroscopy
Patient undergoes an HTO without knee arthroscopy

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC		Preoperatively; 3, 6, 12, 18 and 24 months	No
Secondary	The Lower Extremity Functional Scale (LEFS)		Preoperatively; 3, 6, 12, 18 and 24 months	No
Secondary	Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.		Daily x 2 weeks post surgery; Weekly x 3 months	No
Secondary	SF-12		Preoperatively; 3, 6, 12, 18 and 24 months	No
Secondary	Gait Testing Procedures		6, 12 and 24 months post-operatively	No