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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01614288
First received: June 4, 2012
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Medial Compartment Osteoarthritis of the Knee
Procedure: knee Arthroscopy
Other: No arthroscopy

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

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • WOMAC [ Time Frame: Preoperatively; 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Lower Extremity Functional Scale (LEFS) [ Time Frame: Preoperatively; 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use. [ Time Frame: Daily x 2 weeks post surgery; Weekly x 3 months ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: Preoperatively; 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Gait Testing Procedures [ Time Frame: 6, 12 and 24 months post-operatively ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Active Comparator: Knee Arthroscopy + HTO Procedure: knee Arthroscopy
Patient undergoes a knee arthroscopy and HTO
Active Comparator: HTO Alone Other: No arthroscopy
Patient undergoes an HTO without knee arthroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614288

Locations
Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Study Director: Dianne Bryant, PhD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01614288     History of Changes
Other Study ID Numbers: FKSMC 2010 - 2
Study First Received: June 4, 2012
Last Updated: February 6, 2013
Health Authority: Canada: Ethics Reveiw Board, The University of Western Ontario

Keywords provided by University of Western Ontario, Canada:
HTO
Arthroscopy
Quality-of-Life
Gait Analysis

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

ClinicalTrials.gov processed this record on July 29, 2014