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

Knee Arthritis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00894218
• Other study ID #: 2007-26
• Secondary ID: 2007-A0084845
• Status: Terminated
• Phase: N/A
• First received: May 4, 2009
• Last updated: February 24, 2014
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Knee Arthritis

Intervention

Procedure:
• Arthroplasty
Hip or knee arthroplasty

Locations

Country	Name	City	State
France	Assistance Publique-Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs		2 years after surgery	No