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

NCT ID: NCT04788719

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gait Analysis Hip Arthritis Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Preop Postop

Study Groups

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Preoperative

Gait analysis kinematics and kinetics

Group Type EXPERIMENTAL

Gait analysis

Intervention Type OTHER

Gait analysis

Postoperative

Gait analysis kinematics and kinetics

Group Type EXPERIMENTAL

Gait analysis

Intervention Type OTHER

Gait analysis

Interventions

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Gait analysis

Gait analysis

Intervention Type OTHER

Other Intervention Names

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Kinematics and kinetics

Eligibility Criteria

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Inclusion Criteria

* hip arthritis

Exclusion Criteria

* no hip arthritis
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Zügner

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Roland Zügner

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Pre and post op gait analysis

Identifier Type: -

Identifier Source: org_study_id

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