Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788719
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2021-03-05
Brief Title:
Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Pre and Postoperative Gait Analysis of Randomized Patients to 2 Different Cement Fixation Methods
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None