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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01614288

Enrollment

Registered

2012-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medial Compartment Osteoarthritis of the Knee

Keywords

HTO, Arthroscopy, Quality-of-Life, Gait Analysis

Brief summary

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.

Interventions

PROCEDUREknee Arthroscopy

Patient undergoes a knee arthroscopy and HTO

OTHERNo arthroscopy

Patient undergoes an HTO without knee arthroscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
WOMAC	Preoperatively; 3, 6, 12, 18 and 24 months

Secondary

Measure	Time frame
The Lower Extremity Functional Scale (LEFS)	Preoperatively; 3, 6, 12, 18 and 24 months
Patient Diary to asses swelling, pain and frequency of analgesic and NSAID use.	Daily x 2 weeks post surgery; Weekly x 3 months
SF-12	Preoperatively; 3, 6, 12, 18 and 24 months
Gait Testing Procedures	6, 12 and 24 months post-operatively

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026