Condition category
Musculoskeletal Diseases
Date applied
14/06/2013
Date assigned
06/08/2013
Last edited
06/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A new program aiming to improve a fast comfortable recovery after total knee replacement is called the Lazirush concept or the “2-day Knee”. By not using pain pumps, drains or catheters the risk for infection will be minimized. Also during the operation no tourniquet (bandage) will be used, which will reduce bleeding and swelling after surgery thereby leading to a possible faster activation of muscle function and performance. The inventor of the procedure, Dr Gijzelings (AZ Alma, Eeklo, Belgium) has 10 years of clinical experience with the Lazirush concept. Reports of the patient outcome have been very successful showing improved short-term functional outcome.
The aim of the study is to evaluate the early and late postoperative results of the Scorpio knee prosthesis following the Lazirush concept and compare this with a group of patients undergoing a Scorpio knee prosthesis following the Joint Care concept.

Who can take participate?
Patients requiring a total knee replacement.

What does the study involve?
Patients are randomly allocated to either group A or group B.
Group A: 25 patients undergoing total knee replacement, operated and treated by the “traditional Joint Care concept”
Group B: 25 patients undergoing total knee replacement, operated and treated by the “Lazirush” concept”
Patients are then followed until 12 weeks after surgery. Usual clinical data will be collected and particularly quality of life will be assessed.

What are the possible benefits and risks of participating?
Information obtained from this study may increase the knowledge about the Lazirush and Joint Care concept in total knee replacement.
The study involves the routine assessment of a knee replacement procedure. The devices are CE marked and will be used according to their labelling. At 6 weeks one additional long leg X-ray will be taken. The additional radiation dose is negligible and will do the patient no harm.

Where is the study run from?
Medisch Centrum Alkmaar, Netherlands.

When is the study starting and how long is it expected to run for?
The study will run from May 2011 to December 2012.

Who is funding the study?
Stryker

Who is the main contact?
Eric Garling, Stryker

Trial website

Contact information

Type

Scientific

Primary contact

Mr Eric Garling

ORCID ID

Contact details

Stryker Nederland BV
Koeweistraat 8
Waardenburg
4181CD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

K-S-029

Study information

Scientific title

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

Acronym

Study hypothesis

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 group of patients undergoing a Scorpio knee prosthesis following the Joint Care concept.

Ethics approval

The Medical Ethical Committee (METC) North Holland (Medisch Ethische Toetsingscommissie Noord-Holland); 7 April 2011; kenmerk:NH011.154, METC-registratie M010-043, CCMO-registratie:NL33089.094.10

Study design

Single centre randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary unilateral total knee replacement

Intervention

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 arthroplasty (TKA), operated and treated by the traditional joint care concept
Group B: 25 patients with TKA, operated and treated by the Lazirush concept

Patients are then followed until 12 weeks after surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/05/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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.

Recruitment start date

01/05/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Stryker Nederland BV
Waardenburg
4181CD
Netherlands

Sponsor information

Organisation

Stryker SA (Switzerland)

Sponsor details

Cité-Centre
Grand-Rue 90
Montreux
1820
Switzerland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Stryker SA (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes