Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods
Primary Purpose
Gait Analysis, Hip Arthritis, Total Hip Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Gait analysis
Sponsored by
About this trial
This is an interventional treatment trial for Gait Analysis
Eligibility Criteria
Inclusion Criteria:
- hip arthritis
Exclusion Criteria:
- no hip arthritis
Sites / Locations
- Roland Zügner
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Preoperative
Postoperative
Arm Description
Gait analysis kinematics and kinetics
Gait analysis kinematics and kinetics
Outcomes
Primary Outcome Measures
Kinematics
Hip angels in 3 planes
Kinematics
Hip angels in 3 planes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04788719
Brief Title
Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods
Official Title
Pre and Postoperative Gait Analysis of Randomized Patients to 2 Different Cement Fixation Methods
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Analysis, Hip Arthritis, Total Hip Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Preop Postop
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative
Arm Type
Experimental
Arm Description
Gait analysis kinematics and kinetics
Arm Title
Postoperative
Arm Type
Experimental
Arm Description
Gait analysis kinematics and kinetics
Intervention Type
Other
Intervention Name(s)
Gait analysis
Other Intervention Name(s)
Kinematics and kinetics
Intervention Description
Gait analysis
Primary Outcome Measure Information:
Title
Kinematics
Description
Hip angels in 3 planes
Time Frame
Preop
Title
Kinematics
Description
Hip angels in 3 planes
Time Frame
Postop 2 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
hip arthritis
Exclusion Criteria:
no hip arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Zügner
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roland Zügner
City
Gothenburg
ZIP/Postal Code
SE 41310
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to make individual participant data (IPD) after publication
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
After publication
Learn more about this trial
Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods
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