Scorpio knee prosthesis following the Lazirush concept versus Scorpio knee prosthesis following the joint care concept

Not Applicable

Completed

• Conditions: Primary unilateral total knee replacement; Musculoskeletal Diseases

• Registration Number: ISRCTN51839535
• Lead Sponsor: Stryker SA (Switzerland)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30027483 [added 17/01/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-12-31
• Study Start: 2013-08-06
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients willing to sign the informed patient consent form.
2. Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
3. Patients requiring a primary unilateral total knee replacement.
4. Patients with American Society of Anesthesiologists (ASA) Physical status 1 & 2.
5. Patients having a partner at home for assistance.

Exclusion Criteria

1. Patients with Rheumatoid arthritis, insulin-dependent diabetes, severe osteoporosis, or an inflammatory cause for osteoarthritis.
2. Patients with other lower limb problems than their planned primary unilateral total knee arthroplasty.
3. Patients requiring revision knee surgery.
4. Patients with ASA physical status more than 2.
5. Patients requiring bilateral total knee replacement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this feasibility study for a multi center study the primary objective is to evaluate the early and late postoperative results measured by the Knee Society Score (KSS) and Range of Motion (ROM) of the Scorpio knee prosthesis following the Lazirush concept and compare this with a matched group of patients undergoing a Scorpio knee prosthesis following the Joint Care concept. The data of the range of motion measurements and the KSS will be analyzed with parametrical statistical techniques, such as t-tests, unless the normality assumption does not seem reasonable for the data, in which case non-parametric techniques will be considered e.g. Wilcoxon/Mann-Whitney tests. All data will be analyzed by blinded researchers. KSS is measured at pre-operative visit and then at Week 2, 6 and 12 after surgery. ROM is measured at pre-operative visit and then at Day 1, 2, 3, 4, 5, 6, 7, and Week 2, 6 and 12 after surgery.