Stryker NTX registry

• Register: ISRCTN
• Last refreshed on: 30 March 2021
• Main ID: ISRCTN17022568
• Date of registration: 22/03/2013
• Prospective Registration: No
• Primary sponsor: Stryker European Operations BV (Netherlands)
• Public title: Stryker NTX registry
• Scientific title: Scorpio NRG, Triathlon Total Knee, Triathlon PKR with X3 Insert International Multicentre Outcomes Register
• Date of first enrolment: 01/06/2012
• Target sample size: 1600
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17022568
• Study type: Observational
• Study design: European multicentre prospective follow-up of a consecutive series of patients (Treatment)
• Phase: Not Applicable

Countries of recruitment

Germany, Luxembourg, United Kingdom

Contacts

• Name: Britta von den Brincken

Key inclusion & exclusion criteria

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

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Both

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.
Musculoskeletal Diseases
Arthrosis, unspecified

Intervention(s)

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.

Primary Outcome(s)

Survivorship of the implant; pre-operative, intra-operative and 1 year, 3 years, 5 years, 7 years and 10 years follow-up

Secondary Outcome(s)

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

Secondary ID(s)

K-S-044

NCT02525562

Source(s) of Monetary Support

Stryker European Operations BV (Netherlands)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Date Completed: 25/03/2021