Back to resultsGait Pattern Between a Cemented and Non-cemented Femur Stem
Primary Purpose
Gait Analysis, Hip Fractures, 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:
- acute collum femoris fracture
Exclusion Criteria:
-
Sites / Locations
- Roland Zügner
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gait analysis of cemented total hip
Gait analysis of non-cemented total hip
Arm Description
Gait analysis of acute collum femoris fracture patient randomized to cemented stem
Gait analysis of acute collum femoris fracture patient randomized to non-cemented stem
Outcomes
Primary Outcome Measures
Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty
Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes
Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty
Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04791605
Brief Title
Gait Pattern Between a Cemented and Non-cemented Femur Stem
Official Title
No Difference in Gait Pattern Between a Cemented and Non-cemented Femur Stem. 45 Prospective Randomized Total Hip Arthroplasty Patients After Acute Cervical Femur Fracture Evaluated After 2 Years
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
February 28, 2021 (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
Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.
Detailed Description
45 patients randomized to receive either a cemented or a non-cemented stem were studied . 2 years after the operation gait analysis was performed with a 16-camera motion capture system together with 2 force-plates. Hip kinematics and kinetics were analysed and 70 subjects served as controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Analysis, Hip Fractures, Hip Arthroplasty, Randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Gait of cemented femur stem of acute cervical collum femoris stem. Gait of non-cemented femur stem of acute cervical collum femoris stem.
Masking
Outcomes Assessor
Masking Description
Cemented femur stem Non-cemented femur stem
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gait analysis of cemented total hip
Arm Type
Experimental
Arm Description
Gait analysis of acute collum femoris fracture patient randomized to cemented stem
Arm Title
Gait analysis of non-cemented total hip
Arm Type
Experimental
Arm Description
Gait analysis of acute collum femoris fracture patient randomized to non-cemented stem
Intervention Type
Other
Intervention Name(s)
Gait analysis
Intervention Description
Kinematic and kinetic analysis
Primary Outcome Measure Information:
Title
Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty
Description
Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes
Time Frame
2 year postop
Title
Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty
Description
Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes
Time Frame
2 year postop
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
acute collum femoris fracture
Exclusion Criteria:
-
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
Learn more about this trial
Gait Pattern Between a Cemented and Non-cemented Femur Stem
We'll reach out to this number within 24 hrs