We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00894218
Recruitment Status : Terminated
First Posted : May 6, 2009
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Hip Arthritis Knee Arthritis Procedure: Arthroplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : April 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs [ Time Frame: 2 years after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00894218


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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00894218     History of Changes
Other Study ID Numbers: 2007-26
2007-A0084845
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases