Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Centre Hospitalier Universitaire Dijon.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02042586
First received: January 17, 2014
Last updated: January 20, 2014
Last verified: March 2011
  Purpose

The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".

To this end, the study will take place as follows:

Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis


Condition Intervention
Hip Osteoarthritis
Indication for Total Hip Replacement
Other: Analysis of movement before total hip replacement
Other: Analysis of movement after total hip replacement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Degree of patient statisfaction [ Time Frame: Before and between 6 months and 1 year after total hip replacement ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients Other: Analysis of movement before total hip replacement Other: Analysis of movement after total hip replacement
Controls Other: Analysis of movement before total hip replacement

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

hip osteoarthritis indication for total hip replacement

Criteria

Inclusion Criteria:

Control group:

  • Subjects who have provided written informed consent
  • Subjects covered by the national health insurance scheme
  • Men or women aged between 25 and 85 years
  • able to understand simple instructions and packaging instructions and able to give informed consent

Patients group:

  • Patients who have provided written informed consent
  • Patients covered by the national health insurance scheme
  • Men or women aged between 25 and 85 years
  • able to understand simple instructions and packaging instructions and to give their informed consent
  • Suffering from hip osteoarthritis defined according to ACR criteria
  • Most recent radiography examination less than 6 months earlier
  • Radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification
  • Presenting with an indication for total hip replacement, according to the surgeon's usual criteria

Exclusion Criteria:

Control group:

  • Hip osteoarthritis or other arthrosis in the lower limbs
  • Pregnant or breast-feeding women
  • Disorders that may interfere with gait analysis
  • Disorder that may be destabilized by gait analysis
  • Neurological disease and/or motor neuron disease

Patients group:

  • Contra-indication for total hip replacement
  • Repeat surgery for total hip replacement
  • Impossibility to use a standard implant
  • Pregnant or breast-feeding women
  • Inflammatory flare of the hip osteoarthritis
  • Disorder that may interfere with gait analysis
  • Disorder that may be destabilized by gait analysis
  • Rapidly destructive hip osteoarthritis
  • Neurological disease and/or motor neuron disease
  • Hip dysplasia requiring THR to be completed using a graft
  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: NCT02042586

Contacts
Contact: Pierre TROUILLOUD 3.80.29.33.07 ext +33 pierre.trouilloud@chu-dijon.fr

Locations
France
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Pierre TROUILLOUD    3.80.29.33.07 ext +33    pierre.trouilloud@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02042586     History of Changes
Other Study ID Numbers: TROUILLOUD AOI 2007
Study First Received: January 17, 2014
Last Updated: January 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014