Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.

NCT01814384 | Unknown

• 1 other identifier: RC 12_0100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients. Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.

Conditions

Osteoarthritis

Keywords

Ancillary tailored; medico-economic study,; total knee replacement; primary or secondary osteoarthritis

Outcome Measures

Primary Outcomes (1)

• compare the functionality of the knee after installation of a total knee replacement between the 2 groups

  The evaluation will use a specific score for total knee arthroplasty: Part of the Knee Society function score (KSS) measured at 1 year after surgery.

  2 years after

Secondary Outcomes (2)

• to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary

  2 years after

• medico-economic evaluation type "Cost minimization"

  2 years after

Study Arms (2)

Control group

OTHER

Control group will be constituted of patients with the prosthesis GMK ® without the ancillary MyKnee ® LBS.

Device: prosthesis GMK ® without the ancillary MyKnee ® LBS

Matched patient

OTHER

Treated group will consist of patients which the GMK ® prosthesis with ancillary ® MyKnee LBS.

Device: Matched patient cutting blocks MyKnee ® LBS

Interventions

prosthesis GMK ® without the ancillary MyKnee ® LBS DEVICE

Control group

Matched patient cutting blocks MyKnee ® LBS DEVICE

Matched patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

You may not qualify if:

• distorded axes or laxity requiring the establishment of constrained prosthesis

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital of Nantes

Nantes, France, 44000, France

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 19, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

FR (1)