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HTO With and Without Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284622
Recruitment Status : Unknown
Verified January 2009 by Fowler Kennedy Sport Medicine Clinic.
Recruitment status was:  Not yet recruiting
First Posted : February 1, 2006
Last Update Posted : January 29, 2009
Information provided by:
Fowler Kennedy Sport Medicine Clinic

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Medial Compartment Osteoarthritis of the Knee Procedure: Arthroscopy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Intervention Details:
  • Procedure: Arthroscopy
    HTO with pre-scope

Primary Outcome Measures :
  1. self-reported quality of life (WOMAC). [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. self-reported functional ability (LEFS), [ Time Frame: 2 years ]
  2. swelling [ Time Frame: 2 years ]
  3. pain [ Time Frame: 2 yrs ]
  4. frequency of analgesic use (patient diary), [ Time Frame: 3 mths ]
  5. general health (SF-36). [ Time Frame: 2 yrs ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00284622

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Contact: J.. Robert Giffin, MD, FRCSC 519-661-2111 ext 87505
Contact: Sharon H Griffin, CCS, 519-661-2111 ext 87505

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Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Principal Investigator: J.Robert Giffin, MD, FRCSC         
Sub-Investigator: Dianne Bryant, MSc, PhD         
Sub-Investigator: Kevin Willits, MD, FRCSC         
Principal Investigator: Robert B Litchfield, MD. FRCSC         
Principal Investigator: David Holdsworth, PhD         
Principal Investigator: Alison Spouge, MD, FRCCP         
Sponsors and Collaborators
Fowler Kennedy Sport Medicine Clinic
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Principal Investigator: J. Robert Giffin, MD, FRCSC Fowler Kennedy Sport Medicine Clinic
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Responsible Party: Robert Giffin, FKSMC Identifier: NCT00284622    
Other Study ID Numbers: HTO-1
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009
Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Varus gonarthrosis
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases