Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Mr Pierre-Jacob Le Roux


Contact details

Medical And Scientific Affairs
Stryker France S.A.S.
ZAC Avenue de Satolas Green

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

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



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
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


Secondary study design

Case series

Trial setting


Trial type


Patient information sheet

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


Osteoarthritis, rheumatoid arthritis, avascular necrosis, traumatic arthritis or other diseases requiring total knee arthroplasty or partial knee resurfacing.


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



Not Applicable

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

Germany, Luxembourg, United Kingdom

Trial participating centre

CH Luxembourg

Trial participating centre

Erler Klinik

Trial participating centre

Alexandra Hospital
B98 7UB
United Kingdom

Sponsor information


Stryker European Operations BV (Netherlands)

Sponsor details

Herikerbergweg 110
1101 CM

Sponsor type




Funder type


Funder name

Stryker European Operations BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-review journal

Intention to publish date


Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.