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Completed

NCT Number: NCT04788719

Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Two different cement fixation methods are used in order to insert THR implants. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. Gait analysis preoperative and 2 year after surgery.

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Key information

Conditions

Gait Analysis Hip Arthritis Total Hip Arthroplasty

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roland Zügner

Gothenburg, SE 41310, Sweden

About this study

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Patients with radiological signs of osteoarthritis of the hip, hip pain and functional disability may be treated with insertion of a THA.

Two different fixation methods are used in order to insert THR implants. Cemented fixation using bone cement, polymethyl methacrylate (PMMA) is the most commonly used fixation method in Sweden. A new bone cement, Refobacin®, already marketed in Germany is planned to be introduced in Sweden in late 2018.

The hospital is also equipped with a modern gait laboratory were the functional gait performance can be evaluated. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. The subjects will undergo gait analysis befor and 2 year after surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • hip arthritis

Exclusion criteria

  • no hip arthritis

Treatment and study plan

Gait Analysis

Other

Gait analysis

Other names: Kinematics and kinetics

Primary outcomes

  1. Kinematics

    Time frame: Preop

    Hip angels in 3 planes

  2. Kinematics

    Time frame: Postop 2 year

    Hip angels in 3 planes

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Pre and Postoperative Gait Analysis of Randomized Patients to 2 Different Cement Fixation Methods

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 9, 2021
Registry last updated
Sep 9, 2021

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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