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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

Primary Purpose

Hip Arthritis, Knee Arthritis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arthroplasty
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Arthritis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique-Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional arthroplasty

Mini-invasive arthroplasty

Mini-invasive and computer-assisted arthroplasty

Arm Description

Total hip or knee conventional arthroplasty

Total hip or knee mini-invasive arthroplasty

Mini-invasive and computer-assisted total hip or knee arthroplasty

Outcomes

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

Secondary Outcome Measures

Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs

Full Information

First Posted
May 4, 2009
Last Updated
February 24, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00894218
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthritis, Knee Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional arthroplasty
Arm Type
Active Comparator
Arm Description
Total hip or knee conventional arthroplasty
Arm Title
Mini-invasive arthroplasty
Arm Type
Experimental
Arm Description
Total hip or knee mini-invasive arthroplasty
Arm Title
Mini-invasive and computer-assisted arthroplasty
Arm Type
Experimental
Arm Description
Mini-invasive and computer-assisted total hip or knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Arthroplasty
Intervention Description
Hip or knee arthroplasty
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs
Time Frame
2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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