Condition category
Musculoskeletal Diseases
Date applied
21/01/2013
Date assigned
22/03/2013
Last edited
22/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
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 France, Germany, Luxembourg, United Kingdom..

When does the study take place?
The study started in 2012 and will run till December 2024.

Who is funding the study?
Stryker SA

Who is the main contact?
Eric Garling

Trial website

Contact information

Type

Scientific

Primary contact

Mr Eric Garling

ORCID ID

Contact details

Stryker Nederland BV
Koeweistraat 8
Waardenburg
4181CD
Netherlands
eric.garling@stryker.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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), approval #201109/01 obtained on 14 September 2011
2. Maria Middelares, Belgium: AZ Maria Middelares Ethic Committee, approval #PB/nm/2011.77 obtained on 07 December 2011
3. Erler Klinik, Nurnberg, Germany: Ethik-Kommission der Bayerischen Landesärztekammer, approval #11112 obtained on 02 November 2011
4. Media Park Klinik, Köln, Germany: Arztekammer Nordrhein Ethikkommission, approval #2012132 obtained on 04 June 2012

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

Non randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below 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

Other

Phase

Not Applicable

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

31/12/2024

Locations

Countries of recruitment

France, Germany, Luxembourg, United Kingdom

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
pierre-jacob.leroux@stryker.com

Sponsor type

Industry

Website

http://www.stryker.ch

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