Feasibility study to evaluate the clinical outcome of the Scorpio knee prosthesis following THE LAZIRUSH CONCEPT

Completed

Conditions: Knee arthrosis
10023213

Registration Number: NL-OMON34366

Lead Sponsor: Stryker SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

A.Patients willing to sign the EC approved, study specific Informed Patient Consent Form.
B.Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
C.Patients requiring a primary unilateral total knee replacement.
D.Patients with ASA Physical status 1 &2.
E. Patients having a partner at home for assistence.

Exclusion Criteria

A.Patients with Rheumatoid arthritis, insulin dependent diabetes, severe osteoporosis, or an inflammatory cause for osteoarthritis.
B.Patients with other lower limb problems than their planned primary unilateral total knee arthroplasty.
C.Patients requiring revision knee surgery.
D.Patients with ASA physical status more than 2.
E.Patients requiring bilateral total knee replacement

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the early and late postoperative results measured by the KSS and<br /><br>ROM of the Scorpio knee prosthesis following the Lazirush concept and compare<br /><br>this with a matched group of patients undergoing a Scorpio knee prosthesis<br /><br>following the Joint Care concept.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the early and late postoperative results concerning the incidence<br /><br>and type of postoperative complications, duration of hospital stay, use of pain<br /><br>medication, need for blood transfusion, HB level, drain production, operation<br /><br>parameters, knee swelling, KOOS, Straight leg raise, ambulatory status, single<br /><br>leg stance, ability to walk stairs, X-ray parameters, patient satisfaction,<br /><br>need for home care, resumption of work, chair rise ability, walking speed,<br /><br>amount of pain during rest and activity, and economical costs of the Scorpio<br /><br>knee prosthesis following the Lazirush concept and compare this with a matched<br /><br>group of patients undergoing a Scorpio knee prosthesis following the Joint Care<br /><br>concept.</p><br>