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NCT04788719 Clinical Trial

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

Total Hip Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04788719
Other study ID # Pre and post op gait analysis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date March 1, 2021

Study information
Verified date September 2021
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 1, 2021
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - hip arthritis Exclusion Criteria: - no hip arthritis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Gait analysis
Gait analysis

Locations
Country Name City State
Sweden Roland Zügner Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kinematics Hip angels in 3 planes Preop
Primary Kinematics Hip angels in 3 planes Postop 2 year
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