Medial Opening Wedge High Tibial Osteotomy (HTO) for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fowler Kennedy Sport Medicine Clinic, Western University, London, Canada
Arthrosis+2 More
Medial Opening Wedge High Tibial Osteotomy (HTO) - Procedure
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a surgery to realign the knee can improve outcomes for people with knee osteoarthritis.

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Eligible Conditions

  • Arthrosis
  • Osteoarthritis of the Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Medial Opening Wedge High Tibial Osteotomy (HTO) will improve 1 primary outcome, 9 secondary outcomes, and 1 other outcome in patients with Arthrosis. Measurement will happen over the course of Change from baseline to 24 months post operative.

Month 24
Cost-effectiveness questionnaires
Month 24
Biological Markers of Disease Progression
Gait Biomechanics
Isometric Strength Testing
Numeric Rating Scale for Pain
Month 24
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
MRI articular cartilage morphology
Short-Form 12 (SF12)
Western Ontario Meniscal Evaluation Tool (WOMET)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Non-Surgical Treatment
1 of 2
Non-Surgical Treatment plus HTO
1 of 2
Active Control
Experimental Treatment

This trial requires 71 total participants across 2 different treatment groups

This trial involves 2 different treatments. Medial Opening Wedge High Tibial Osteotomy (HTO) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Non-Surgical Treatment plus HTOThe optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will undergo a medial opening wedge high tibial osteotomy (HTO). They will continue with their home program and will be followed up for 2 years after baseline.
Non-Surgical Treatment
Other
The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will continue with their home program and will be followed up for 2 years after baseline.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12 and 24 months post operative
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 12 and 24 months post operative for reporting.

Who is running the study

Principal Investigator
T. B.
Prof. Trevor Birmingham, Professor
Western University, Canada

Closest Location

Fowler Kennedy Sport Medicine Clinic, Western University - London, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Does this subject present with varus alignment? (Based on hip to ankle x-rays).
Does this subject have clinical Knee OA? (MAA <-2° on full limb standing AP) according to the Altman classification primarily involving the medial compartment of the knee?
25-55 years old?
Older than 55 but still active (ex. physical labour, regular recreational activities)?
Patient is a good candidate for high tibial osteotomy and will be receiving a PEEK plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.

Patient Q&A Section

Can arthrosis be cured?

"Overall improvement in shoulder function and joint stability is frequent. There were no significant differences in the improvement or deterioration in joint stability between the different types of arthrosis. Improvement in shoulder function was relatively small. A substantial proportion of shoulder function, however, was not restored." - Anonymous Online Contributor

Unverified Answer

What is arthrosis?

"Arthrosis means degenerative changes in a joint causing its structural damage and loss of joint mobility. This loss can affect overall joint health and function.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthrosis?

"What we find in this article seems to suggest that many of the treatments available do work and that some of the drugs used can even prevent the onset of arthritis. The evidence gathered is, however, conflicting and not enough to be used by the general public." - Anonymous Online Contributor

Unverified Answer

What causes arthrosis?

"Arthrosis is best classified as an age related condition. Arthrosis is not merely the result of physical factors that are associated with aging such as arthritis, but is also an intrinsic function of aging. This will only be true after the person ages to the age that he or she will develop arthrosis. The prevalence of arthrosis increases as people age because there is a steady deterioration of the articular cartilage over time. Arthrosis may manifest itself in different ways, and different types of arthrosis will have different causes. Thus, it is important that both the person’s medical history and the findings from a physical examination and/or radiographs may be necessary to definitively diagnose arthrosis." - Anonymous Online Contributor

Unverified Answer

What are the signs of arthrosis?

"In our survey, only five patients had a history of the first symptom, which suggests that many people may not have early symptoms of this disease. However, the clinical presentation can be very suggestive. The signs are listed as:\n- local swelling\n- sub-periosteal edema\n- osteophyte formation\n- panniculitis\n- periostitis\n- osteoclast activity\n\nThere are many types of arthrosis, but the most important is osteoarthritis (OA)." - Anonymous Online Contributor

Unverified Answer

How many people get arthrosis a year in the United States?

"A large proportion of men report having symptoms of knee arthrosis at some time in their lives, though a majority report having some degree of pain. There is a need to identify arthrosis as an occupational disease, especially insofar as back pain can cause difficulty working." - Anonymous Online Contributor

Unverified Answer

Does arthrosis run in families?

"We found some evidence for a genetic component to the onset and progression of knee/hip arthrosis. However, we propose caution when interpreting the results of association studies, because of the low power to find the small effect observed." - Anonymous Online Contributor

Unverified Answer

How serious can arthrosis be?

"Patients with severe arthrosis might be at risk of serious complications. The current definition of arthrosis as a degree of cartilage degradation not causing functional impairment should be updated. Clinically, arthrosis should be diagnosed and treated accordingly, considering its potential complications." - Anonymous Online Contributor

Unverified Answer

Is medial opening wedge high tibial osteotomy (hto) typically used in combination with any other treatments?

"The current evidence suggests that HRUO/MOWT is used as part of treatment for patients afflicted with osteoarthritis. As the evidence supporting the efficacy of HRUO/MOWT in patients with osteoarthritis is limited, the combination of this procedure with other treatments to achieve better outcomes in patients with osteoarthritis is warranted." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of arthrosis?

"Arthrosis of the temporomandibular joints is due to a combination of a degenerative process (chronic arthritis and articular disk displacement). The degenerative process may be triggered by a traumatic event or repeated forceful clenching of the TMJ; however, the mechanism by which trauma promotes arthrosis remains unknown. Degenerative arthrosis without accompanying arthritis can occur." - Anonymous Online Contributor

Unverified Answer

What does medial opening wedge high tibial osteotomy (hto) usually treat?

"The majority of patients treated with high tibial osteotomy for knee arthritis have significant pain relief, good to excellent functional and overall physical health at a mean of 12 years postoperatively. For knees with medial compartment knee osteoarthritis, the high rate of successful outcomes with HTO supports the use of HTO as the primary surgical treatment for severe pain." - Anonymous Online Contributor

Unverified Answer

What is the latest research for arthrosis?

"Arthrosis is an important problem in the field of musculoskeletal medicine because of the number of patients that have been subjected to treatment for this disease over the years, and the many new concepts that are being proposed in the field of musculoskeletal medicine. Since then, several new concepts have been added to the medical literature for the treatment and management of arthrosis. These concepts are intended to find the causes of this disorder and to minimize its symptoms during the patient's life. Some of the most widely publicized are: arthroscopic surgery, intra-articular injections (botulinum toxin and hyaluronic acid), cell therapy, osteopathic medicine, physical therapy and joint lavage after arthrosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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