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Completed

NCT Number: NCT01797003

Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.

Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martina Hansens Hospital

Oslo, 0756, Norway

About this study

Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.

Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.

In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medial osteoarthritis in the knee (x-ray and arthroscopy)
  • Pain in medial compartment of the knee
  • Correction angle of 5 degrees or more

Exclusion criteria

  • Former or active infection in the knee
  • Rheumatoid arthritis or other similar disease
  • Cancer
  • Neurological disease
  • Kidney disease or metabolic disease

Treatment and study plan

High tibial osteotomy

Other

Primary outcomes

  1. Kne injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 2 years postoperataively

    The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.

Secondary outcomes

  1. Range of motion (ROM)

    Time frame: 2 years postoperatively

    The change in ROM are followed at several time points the first 2 years. ROM will be measured 3 months, 6 months, 1 year and 2 years postoperatively.

Other outcomes

  1. Oxford knee score

    Time frame: 2 years

    The change in Oxford score are followed at several time points the first 2 years. Patients will be evaluated with Oxford knee score, 3 months, 6 months, 1 year and 2 years postoperatively.

  2. Lysholm score

    Time frame: 2 years postoperatively

    The change in Lysholm score are followed at several time points the first 2 years. Patients will be evaluated with Lysholm, 3 months, 6 months, 1 year and 2 years postoperatively.

  3. UCLA activity scale

    Time frame: 2 years postoperatively

    The change in UCLA scale are followed at several time points the first 2 years. Patients will be evaluated with UCLA activity scale, 3 months, 6 months, 1 year and 2 years postoperatively.

  4. Tegner Activity Score

    Time frame: 2 years postoperatively

    The change in Tegner score are followed at several time points the first 2 years. Patients will be evaluated with Tegner score, 3 months, 6 months, 1 year and 2 years postoperatively.

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2013
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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