- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474031
Prospective Study Deltamotion - DAA THA Study
Introduction Few gait analytical data are available concerning the Direct Anterior Approach (DAA) in total hip arthroplasty (THA). All the studies have focused on immediate post-operative recovery. These studies have in general some important shortcomings in order to accurately evaluate the biomechanics of the replaced hip joint. None of the published reports have reported on consecutive intervals of pre-op - 6w - 3m - 6m - 12m. This is of interest as we know that recovery with other approaches takes >1 year. It might be that the DAA approach leads to normal gait patterns at 3m or 6m and that these patterns do not differ from the normal pattern or at >1y post-op. None of the reports utilized out-of-plane movements such as coming down or up stairs or squads. Utilizing trunk markers is frequently not done but it is important to evaluate the centre of mass position during gait. Very few studies utilize kinetic data, which are important in order to thoroughly evaluate the biomechanics and loading of the hip. And maybe most importantly, the biomechanical effect of the diameter of the articulating surface on gait parameters following the DAA has never been evaluated.
One of the most important advantages of the DAA is the muscle sparing aspect and the presumption that the femoral anatomy and biomechanics can be more accurately and precisely restored. If the diameter of the articulating surface has then also been reconstructed to the almost anatomical diameter, we can assume that this should be the most optimal reconstruction of the hip joint currently available. This could lead to early return to normal gait, to optimal joint loading and a minimal amount of stress shielding of the femoral bone.
The aim of this project is to prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach.
- Materials and Methods Hypothesis: The temporo-spatial parameters (velocity, cadence, step length, and stride length) and gait kinematic and kinetic data (external hip and knee muscle moments) are not significantly different between the study and control group at the evaluated time intervals indicating normal or near normal gait patterns in the early post-operative recovery phase.
Study Overview
Detailed Description
Estimated inclusion time: 1 July 2011 - 31 December 2013 Cohorts: 20 DAA subjects - 20 control subjects
Assessments:
- Time interval: pre-op - 3m - 6m - 12m
Gait analysis with surface EMG and trunk markers:
- Unipodal standing: 3 trials Right and 3 trials Left on FP
- Level walking: 3 trials Right and 3 trials Left on FP
- Chair rise: 3 trials, both legs on FP
- Stair ascent: 3 trials Right and 3 trials Left on first FP
- Stair descent: 3 trials Right and 3 trials Left on first FP
- Squat: 3 trials, both legs on FP
- Bipodal squat: 3 trials Right and 3 trials Left on FP
- Functional scores (HHS, UCLA, HOOS, SF-36)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Leuven, Belgium, 3000
- UZ Pellenberg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: 20-75 years
- BMI: < 30kg/m2
- Diagnosis: unilateral primary and secondary osteoarthritis treated with the Deltamotion THA with a Corail stem
Exclusion Criteria:
- Osteoarthritis other joints and low back impairment
- LLD > 5mm
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
20 DAA subjects
20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
|
|
Control group
healthy volunteers
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biomechanics
Time Frame: 0.5 year
|
prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
|
0.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bone remodelling
Time Frame: 1 year
|
assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kristoff Corten, Doctor, UZ Pellenberg
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s52629
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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