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
2 other identifiers
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 4, 2009
CompletedFirst Posted
Study publicly available on registry
May 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 25, 2014
February 1, 2014
1 year
May 4, 2009
February 24, 2014
Conditions
Outcome Measures
Primary Outcomes (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
2 years after surgery
Secondary Outcomes (1)
Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs
2 years after surgery
Study Arms (3)
Conventional arthroplasty
ACTIVE COMPARATORTotal hip or knee conventional arthroplasty
Mini-invasive arthroplasty
EXPERIMENTALTotal hip or knee mini-invasive arthroplasty
Mini-invasive and computer-assisted arthroplasty
EXPERIMENTALMini-invasive and computer-assisted total hip or knee arthroplasty
Interventions
Hip or knee arthroplasty
Eligibility Criteria
You may qualify if:
- Weight \< 100 kg
- score UCLA \> 4
- prosthesis of first intention
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique-Hopitaux de Marseille
Marseille, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2009
First Posted
May 6, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 25, 2014
Record last verified: 2014-02