Scorpio knee prosthesis following the Lazirush concept versus Scorpio knee prosthesis following the joint care concept
| ISRCTN | ISRCTN51839535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51839535 |
| Secondary identifying numbers | K-S-029 |
- Submission date
- 14/06/2013
- Registration date
- 06/08/2013
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Stryker Nederland BV
Koeweistraat 8
Waardenburg
4181CD
Netherlands
Study information
| Study design | Single centre randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Feasibility study to evaluate the clinical outcome of the Scorpio knee prosthesis following the Lazirush concept |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
4181CD
Netherlands
Sponsor information
Industry
Cité-Centre
Grand-Rue 90
Montreux
1820
Switzerland
"ROR" |
https://ror.org/04t7jet59 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Only aggregated data will be included included in the results publication to ensure no GDPR breaches. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2018 | 17/01/2019 | Yes | No |
Editorial Notes
18/01/2019: IPD sharing statement added.
17/01/2019: Publication reference added.
