Condition category
Musculoskeletal Diseases
Date applied
21/01/2013
Date assigned
22/03/2013
Last edited
05/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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?
Pierre-Jacob Le Roux
pierre-jacob.leroux@stryker.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Pierre-Jacob Le Roux

ORCID ID

Contact details

Medical And Scientific Affairs
Stryker France S.A.S.
ZAC Avenue de Satolas Green
Pusignan
69330
France
-
pierre-jacob.leroux@stryker.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02525562

Protocol/serial number

K-S-044

Study information

Scientific title

Scorpio NRG, Triathlon Total Knee, Triathlon PKR with X3 Insert International Multicentre Outcomes Register

Acronym

NTX

Study hypothesis

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

1. CH Luxembourg, Clinique d’Eich, Luxembourg: CNER (Comité National d’Ethique 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

Study design

European multicentre prospective follow-up of a consecutive series of patients

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2012

Overall trial end date

31/12/2024

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1600

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2012

Recruitment end date

11/03/2014

Locations

Countries of recruitment

Germany, Luxembourg, United Kingdom

Trial participating centre

CH Luxembourg
L-1210
Luxembourg

Trial participating centre

Erler Klinik
Nürnberg
90429
Germany

Trial participating centre

Alexandra Hospital
Redditch
B98 7UB
United Kingdom

Sponsor information

Organisation

Stryker European Operations BV (Netherlands)

Sponsor details

Herikerbergweg 110
Amsterdam
1101 CM
Netherlands
-
pierre-jacob.leroux@stryker.com

Sponsor type

Industry

Website

http://www.stryker.com/

Funders

Funder type

Industry

Funder name

Stryker European Operations BV (Netherlands)

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

05/01/2017: France was removed from the countries of recruitment.