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Prospective Study Deltamotion - DAA THA Study

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ClinicalTrials.gov Identifier: NCT01474031
Recruitment Status : Terminated (Main investigator has left the department and therefore the study had ended)
First Posted : November 17, 2011
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
  1. 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.

  2. 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.

Condition or disease Intervention/treatment
Arthrosis Other: Biomechanics

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)

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Deltamotion - DAA THA Study
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
20 DAA subjects
20 DAA subjects: THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach
Other: Biomechanics
  • Time interval: pre-op - 3m - 6m - 12m
  • Assessment of all subjects:

    • XR
    • 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)

Control group
healthy volunteers
Other: Biomechanics
  • Time interval: pre-op - 3m - 6m - 12m
  • Assessment of all subjects:

    • XR
    • 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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. bone remodelling [ Time Frame: 1 year ]
    assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
20 DAA subjects
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474031


Locations
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Belgium
UZ Pellenberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
DePuy International
Investigators
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Principal Investigator: Kristoff Corten, Doctor UZ Pellenberg
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01474031    
Other Study ID Numbers: s52629
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: August 2011
Keywords provided by Universitaire Ziekenhuizen Leuven:
total hip arthroplasty
biomechanics
direct anterior approach
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases