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

Not Applicable

Completed

• Conditions: Gait Analysis; Hip Arthritis; Total Hip Arthroplasty
• Interventions: Other: Gait analysis

• Registration Number: NCT04788719
• Lead Sponsor: Göteborg University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• hip arthritis

Exclusion Criteria

• no hip arthritis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Postoperative	Gait analysis	Gait analysis kinematics and kinetics
Preoperative	Gait analysis	Gait analysis kinematics and kinetics

Primary Outcome Measures

Name	Time	Method
Kinematics	Postop 2 year	Hip angels in 3 planes

Trial Locations

Locations (1)

Roland Zügner; 🇸🇪 Gothenburg, Sweden