HTO With and Without Arthroscopy

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

It remains unknown if a concomitant arthroscopic knee debridement would increase the benefits of surgery (quality of life and functional ability) for young active patients with medial compartment OA of the knee and varus alignmen. This additional procedure has a low incidence of morbidity and would potentially allow for treatment of meniscal tears and articular damage, as well as joint lavage to remove debris and inflammatory factors. A trial is needed to determine whether HTO with concomitant knee arthroscopy will result in better overall outcomes for this patient group.The objective is to compare the quality of life, functional status, pain, and swelling of patients who undergo an HTO with or without a concomitant knee joint arthroscopy to address additional joint pathology

Study Overview

• Status: Unknown
• Conditions: Medial Compartment Osteoarthritis of the Knee
• Intervention / Treatment: Procedure: Arthroscopy

Detailed Description

Arthroscopy for degenerative conditions of the knee is among the most widely employed orthopaedic procedures, but its effectiveness (like the effectiveness of many surgical operations) has never been proven in prospective trials. The evidence supporting the use of arthroscopy in treatment algorithms for knee OA comes largely from case series and cohort studies. These studies have shown that about 50% of patients report pain relief following the procedure. Predictors of poor outcome following arthroscopy include marked mal-alignment, restricted range of motion, advanced radiographic changes, and prior surgery. Improved outcomes are predicted by preoperative mechanical symptoms caused by loose bodies, meniscal tears, or radiographic evidence of mild articular degeneration.

The proposed study is a randomized clinical trial.

Each patient will undergo a preoperative MRI of their affected knee joint to identify existing pathology (e.g. meniscal tears, loose bodies, chondral flaps). The results of the MRI will not be revealed to physicians, patients or data collectors. This will ensure that we have information on the existing joint pathology within each group and that prognostic variables between groups were sufficiently balanced (i.e. comparable rates of similar pathology per group). The primary outcome measure is self-reported quality of life (WOMAC). Secondary measures include self-reported functional ability (LEFS), swelling, pain and frequency of analgesic use (patient diary), and general health (SF-36). Assessments will take place preoperatively and at 3, 6 and 12 months postoperatively.

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Fowler Kennedy Sport Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with medial compartment osteoarthritis as determined by clinical examination and plain radiographs.
• scheduled for an HTO

Exclusion Criteria:

1. Evidence of other significant knee pathology,
2. Active joint or systemic infection,
3. Major medical illness that would preclude undergoing surgery,
4. Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
5. Major psychiatric illness, developmental handicap or inability to read and understand the English language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
self-reported quality of life (WOMAC).	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
self-reported functional ability (LEFS),	2 years
swelling	2 years
pain	2 yrs
frequency of analgesic use (patient diary),	3 mths
general health (SF-36).	2 yrs

Collaborators and Investigators

• Sponsor: Fowler Kennedy Sport Medicine Clinic
• Investigators: Principal Investigator: J. Robert Giffin, MD, FRCSC, Fowler Kennedy Sport Medicine Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: January 31, 2006
• First Submitted That Met QC Criteria: January 31, 2006
• First Posted (Estimate): February 1, 2006

Study Record Updates

• Last Update Posted (Estimate): January 29, 2009
• Last Update Submitted That Met QC Criteria: January 28, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Osteoarthritis; Arthroscopy; HTO; Alignement; Varus gonarthrosis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HTO-1