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

Feasibility study to evaluate the clinical outcome of the Scorpio knee prosthesis following the Lazirush concept

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51839535

Enrollment

Registered

2013-08-06

Start date

2011-05-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary unilateral total knee replacement Musculoskeletal Diseases

Interventions

The patients who are willing to participate in this study and who signed an informed consent are randomly assigned to group A or group B. Group A: 25 patients with total knee arthropla

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
The secondary outcomes evaluate the early and late postoperative results concerning the incidence and type of postoperative averse events, duration of hospital stay, use of pain medication, need for blood transfusion, HB level, drain production, operation parameters, knee swelling, Knee injury and Osteoarthritis Outcome Score (KOOS), Straight leg raise, ambulatory status, single leg stance, ability to walk stairs, X-ray parameters, patient satisfaction, need for home care, resumption of work, chair rise ability, walking speed, amount of pain during rest and activity, and economical costs 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. Concerning the secondary outcome measures a difference will be made between continuous outcome variables and categorical outcome variables. Continuous outcome variables and their differences will be analysed 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. Categorical outcome variables will be analysed with chi-square tests and/or Fisher's exact tests (depending on the expected values in the categories). For the relevant parameters (e.g. pain and function) also the 95 percent confidence intervals will be calculated. The effect of parameters such as age, sex will be evaluated using multiple variate analysis. All data will be analysed by blinded researchers. All these secondary outcomes are measured at pre-operative visit and then at week 2, 6 and 12 after surgery. For some outcomes, they will also be measured at day 1, 2, 3, 4, 5, 6, 7 after surgery.	—

Measure

Time frame

The secondary outcomes evaluate the early and late postoperative results concerning the incidence and type of postoperative averse events, duration of hospital stay, use of pain medication, need for blood transfusion, HB level, drain production, operation parameters, knee swelling, Knee injury and Osteoarthritis Outcome Score (KOOS), Straight leg raise, ambulatory status, single leg stance, ability to walk stairs, X-ray parameters, patient satisfaction, need for home care, resumption of work, chair rise ability, walking speed, amount of pain during rest and activity, and economical costs 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. Concerning the secondary outcome measures a difference will be made between continuous outcome variables and categorical outcome variables. Continuous outcome variables and their differences will be analysed 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. Categorical outcome variables will be analysed with chi-square tests and/or Fisher's exact tests (depending on the expected values in the categories). For the relevant parameters (e.g. pain and function) also the 95 percent confidence intervals will be calculated. The effect of parameters such as age, sex will be evaluated using multiple variate analysis. All data will be analysed by blinded researchers. All these secondary outcomes are measured at pre-operative visit and then at week 2, 6 and 12 after surgery. For some outcomes, they will also be measured at day 1, 2, 3, 4, 5, 6, 7 after surgery.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026