A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone

NCT02003976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-07-24

No results posted yet for this study

Summary

The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving optimized non-surgical treatment plus surgical realignment of the tibia, or optimized non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months follow-up will suggest favourable changes in patients undergoing surgical realignment when compared to patients receiving non-surgical treatment only.

Conditions

Interventions

PROCEDURE

Medial Opening Wedge High Tibial Osteotomy (HTO)

A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.

OTHER

Non-Surgical Treatment Program

A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.

Sponsors & Collaborators

  • The Arthritis Society, Canada

    collaborator OTHER
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Western University, Canada

    lead OTHER

Principal Investigators

  • Trevor B Birmingham, PT, PhD · Western University

  • J R Giffin, MD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-05
Primary Completion
2023-04-18
Completion
2023-04-26

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02003976 on ClinicalTrials.gov