Prospective Study Deltamotion - DAA THA Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01474031
First received: November 7, 2011
Last updated: November 14, 2011
Last verified: August 2011
  Purpose

Research protocol prospective study Deltamotion - DAA THA study

  1. Introduction Very 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. Muscle strength of the abductors has not been tested. 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 (1) to prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach and (2) to assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.

  2. Materials and Methods Hypothesis: (1) 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. (2) Stress shielding of the bone around the femoral stem as measured with the DEXA scan can be predicted accurately with the FE analysis based on the collected data indicating the validity of the musculoskeletal models.

Estimated inclusion time: 1 July 2011 - 31 December 2011 Cohorts: 20 DAA subjects - 20 control subjects

Assessments:

  • Time interval: pre-op - 3m - 6m - 12m
  • Assessment of all subjects:

    • XR with magnification marker
    • Biodex force measurement in flexion and extension and mid flexion (with EMG if possible)
  • 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)
  • DEXA scan pre-op and at 12 months
  • Assessment of final 5 subjects per group:

    • CT pre and post at 6w (pre: pelvis-knee and post: hip)
    • MRI pre and 1 y post
    • Accelerometer 1 week

Condition Intervention
Arthroplasty, Replacement, Hip
Biomechanics
Other: biomechanics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Deltamotion - DAA THA Study

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • biomechanics [ Time Frame: 0.5 year ] [ Designated as safety issue: No ]
    prospectively analyse the biomechanics of the hip joint of a THA with a Deltamotion articulating surface utilizing the Direct Anterior Approach


Secondary Outcome Measures:
  • bone remodelling [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    assess the femoral bone remodelling around the fully coated Corail stem over the first year post-operatively.


Estimated Enrollment: 40
Study Start Date: October 2011
Groups/Cohorts Assigned Interventions
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 with magnification marker
    • Biodex force measurement in flexion and extension and mid flexion (with EMG if possible)
    • 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)
  • Assessment of final 5 subjects per group:

    • CT pre and post at 6w (pre: pelvis-knee and post: hip)
    • MRI pre and 1 y post
    • Accelerometer 1 week
20 controls
20 healthy controls
Other: biomechanics
  • Time interval: pre-op - 3m - 6m - 12m
  • Assessment of all subjects:

    • XR with magnification marker
    • Biodex force measurement in flexion and extension and mid flexion (with EMG if possible)
    • 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)
  • Assessment of final 5 subjects per group:

    • CT pre and post at 6w (pre: pelvis-knee and post: hip)
    • MRI pre and 1 y post
    • Accelerometer 1 week

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cohorts: 20 DAA subjects - 20 control subjects

Criteria

Inclusion Criteria:

  • Age: 60-75 years
  • Gender: 10 M and 10 F / group
  • BMI: < 30kg/m2
  • Diagnosis: unilateral primary osteoarthritis treated with the Deltamotion THA with a Corail stem

Exclusion Criteria:

  • Secondary osteoarthritis: DDH, RA, post-childhood hip disorders
  • Osteoarthritis other joints and low back impairment
  • LLD > 5mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474031

Locations
Belgium
UZ Pellenberg Recruiting
Leuven, Belgium, 3000
Contact: Liselore Maeckelbergh       liselore.maeckelbergh@student.kuleuven.be   
Principal Investigator: Kristoff Corten         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
DePuy International
Investigators
Principal Investigator: Kristoff Corten, Doctor UZ Pellenberg
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01474031     History of Changes
Other Study ID Numbers: s52629
Study First Received: November 7, 2011
Last Updated: November 14, 2011
Health Authority: Belgium: ethic committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
total hip arthroplasty
biomechanics
direct anterior approach

ClinicalTrials.gov processed this record on July 24, 2014