New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00894218
First received: May 4, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.


Condition Intervention
Hip Arthritis
Knee Arthritis
Procedure: Arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional arthroplasty
Total hip or knee conventional arthroplasty
Procedure: Arthroplasty
Hip or knee arthroplasty
Experimental: Mini-invasive arthroplasty
Total hip or knee mini-invasive arthroplasty
Procedure: Arthroplasty
Hip or knee arthroplasty
Experimental: Mini-invasive and computer-assisted arthroplasty
Mini-invasive and computer-assisted total hip or knee arthroplasty
Procedure: Arthroplasty
Hip or knee arthroplasty

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight < 100 kg
  • score UCLA > 4
  • prosthesis of first intention

Exclusion Criteria:

  • Pregnant
  • score UCLA < 4
  • osteotomy near to prosthesis
  • prosthesis requiring an osseous transplant
  • prosthesis already set up
  • infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis
  • neuromuscular diseases able to perturb walking or staying
  • congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon
  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: NCT00894218

Locations
France
Assistance Publique-Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00894218     History of Changes
Other Study ID Numbers: 2007-26, 2007-A0084845
Study First Received: May 4, 2009
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014