Stryker NTX registry

ISRCTN	ISRCTN17022568
DOI	https://doi.org/10.1186/ISRCTN17022568
ClinicalTrials.gov number	NCT02525562
Secondary identifying numbers	K-S-044

Submission date: 21/01/2013
Registration date: 22/03/2013
Last edited: 15/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The aim of the study is to provide information on safety and efficacy of three types of knee prostheses, manufactured by Stryker.

Who can participate?
Up to 16 hospitals/clinics will participate in the study.
Up to 1600 patients will be included in the study (20-100 per centre).
All patients of one of these centre who are eligible for a total knee arthroplasty replacement surgery with one of the three Stryker knee prostheses (Scorpio NRG/X3, Triathlon/X3, Triathlon PKR/X3) and who have consented to participate can be enrolled in the study.

What does the study involve?
This is an observational study. That means that all the patients participating in the study will be followed according to the current practice of their surgeons. The study will just collect the data (that will be anonymized) to be able to perform statistical analysis and assess the safety and efficacy of the knee prostheses.

What are the possible benefits and risks of participating?
This study does not provide additional risk for the patients, as all the patients are followed according to the common practice of their surgeons. No payment will be done to the patient. The patients will be followed according to the common practice of all the investigators.

Where is the study run from?
This study takes place in Germany, Luxembourg, and the UK

When does the study take place?
June 2012 to December 2024

Who is funding the study?
Stryker European Operations BV (Netherlands)

Who is the main contact?
Britta von den Brincken, britta.vondenbrincken@stryker.com

Contact information

Dr Britta von den Brincken
Scientific

Clinical Operations Stryker Joint Replacement
Dr.-Homer-Stryker-Platz 1
Duisburg
47228
Germany

Phone	+49(0)1638999202
Email	britta.vondenbrincken@stryker.com

Study information

Study design	European multicentre prospective follow-up of a consecutive series of patients
Primary study design	Observational
Secondary study design	Case series
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Scorpio NRG, Triathlon Total Knee, Triathlon PKR with X3 Insert International Multicentre Outcomes Register
Study acronym	NTX
Study objectives	There is no specific study hypothesis as this is an observational study. The objective is to provide outcomes information with regard to surgical and implant performance and patient clinical outcomes of the patients who are eligible for a either a Total Knee Arthroplasty (TKA) replacement surgery involving either: 1. Scorpio NRG Total Knee System with X3 insert 2. Triathlon Total Knee System with X3 insert or 1. Partial Knee Resurfacing (unicompartmental knee arthroplasty, UKA) involving: 2. Triathlon PKR (Partial Knee Resurfacing) System with X3 insert
Ethics approval(s)	1. CH Luxembourg, Clinique dEich, Luxembourg: CNER (Comité National dEthique de Recherche), 14/09/2011, ref: #201109/01 2. Maria Middelares, Belgium: AZ Maria Middelares Ethic Committee, 07/12/2011, ref: #PB/nm/2011.77 3. Erler Klinik, Nurnberg, Germany: Ethik-Kommission der Bayerischen Landesärztekammer, 02/11/2011, ref: #11112 4. Media Park Klinik, Köln, Germany: Arztekammer Nordrhein Ethikkommission, 04/06/2012, ref: #2012132 All other centres will seek ethics approval before recruiting participants
Health condition(s) or problem(s) studied	Osteoarthritis, rheumatoid arthritis, avascular necrosis, traumatic arthritis or other diseases requiring total knee arthroplasty or partial knee resurfacing.
Intervention	It is anticipated that the patients shall be recruited within a 12 month period at each participating centre. The length of surveillance and patient visit schedule is based on the routine procedures of the institution. The surveillance system is set-up to record data at pre-operative, intra-operative and 1 year, 3 years, 5 years, 7 years and 10 years follow-up. Safety during follow-up and Survivorship as described by Kaplan-Meier survival curves Standard clinical parameters and KSS (Knee Society Score) as well as patient questionnaires [EQ5D (EuroQol Group) and KOOS (Knee Injury and Osteoarthritis Outcome Score)] pre-operatively and each follow-up visit.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	1. Scorpio NRG Total Knee System with X3 insert 2. Triathlon Total Knee System with X3 insert 3. Triathlon Partial Knee Resurfacing with X3 insert
Primary outcome measure	Survivorship of the implant; pre-operative, intra-operative and 1 year, 3 years, 5 years, 7 years and 10 years follow-up
Secondary outcome measures	1. Any adverse event 2. Knee Society Score (KSS) 3. Knee Injury and Osteoarthritis Outcome Score (KOOS) 4. EuroQol Group Score (EQ5D) Pre-operative, intra-operative and 1 year, 3 years, 5 years, 7 years and 10 years follow-up
Overall study start date	01/06/2012
Completion date	25/03/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1600
Key inclusion criteria	1. Patients requiring primary Total Knee Arthroplasty (TKA), suitable for the use of the Scorpio NRG with X3 insert or Triathlon Total Knee System with X3 insert, or, patients requiring partial knee resurfacing (unicompartmental knee) suitable for the use of the Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 2. Patients who understand the conditions of the outcomes registry and are willing and able to comply with the standard post-operative evaluations and the prescribed rehabilitation 3. Patients who signed the Informed Consent Form (approved by Ethics Committee if required) prior to surgery
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/2012
Date of final enrolment	11/03/2014

Locations

Countries of recruitment

England
Germany
Luxembourg
United Kingdom

Study participating centres

CH Luxembourg

L-1210
Luxembourg

Erler Klinik

Nürnberg
90429
Germany

Alexandra Hospital

Redditch
B98 7UB
United Kingdom

Sponsor information

Stryker European Operations BV (Netherlands)
Industry

Herikerbergweg 110
Amsterdam
1101 CM
Netherlands

Email	pierre-jacob.leroux@stryker.com
Website	http://www.stryker.com/
"ROR"	https://ror.org/02nwyam20

Funders

Funder type

Industry

Stryker European Operations BV (Netherlands)

No information available

Results and Publications

Intention to publish date	01/07/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Planned publication in a high-impact peer-review journal
IPD sharing plan

Editorial Notes

15/03/2021: The scientific contact has been updated.
01/09/2020: The following changes have been made:
1. The publication and dissemination plan has been added.
2. The intention to publish date has been added.
11/08/2020: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2024 to 25/03/2021.
2. The device phase "Not Applicable" has been added.
3. The drug name(s) have been added.
05/01/2017: France was removed from the countries of recruitment.