Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study

NCT02524730 | Completed Results FDA Device

• 1 other identifier: SLCRG-001-2007 / K-S-002
• Study Type: interventional
• Target: 205
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Survival Rate

  Assess survival (absence of revision) at 7 year follow-up

  7 year follow-up

Secondary Outcomes (5)

• Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)

  Pre-operative, 3 months, 1, 3, 5 and optional 7 years

• Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire

  Pre-operative, 3 months,1, 3, 5 and optional 7 years

• Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)

  Pre-operative, 3 months,1, 3, 5 and optional 7 years

• Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.

  Pre-operative,1, 5 and optional 7 years

• Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).

  Pre-operative, 3 months,1, 3, 5 and optional 7 years

Study Arms (1)

Scorpio NRG CR Total Knee System

OTHER

Primary total knee replacement

Device: Primary total knee replacement (Scorpio NRG CR Total Knee System)

Interventions

Primary total knee replacement (Scorpio NRG CR Total Knee System) DEVICE

Scorpio NRG CR Total Knee System

Scorpio NRG CR Total Knee System

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
• The subject is a male or non-pregnant female between 40 and 75 years of age.
• The subject requires a primary total knee replacement.
• Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis)
• The subject has intact collateral ligaments.
• The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
• The subject is capable of understanding the patient scores in the national language.

You may not qualify if:

• The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40.
• The subject has a history of total or unicompartmental reconstruction of the affected joint.
• The subject will be operated bilaterally.
• Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study).
• Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study).
• Patients who will need lower limb joint replacement for another joint within one year.
• The subject has had a high tibial osteotomy or femoral osteotomy.
• The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
• The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
• The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
• The subject has had a knee fusion to the affected joint.
• The subject has an active or suspected latent infection in or about the knee joint.
• Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).
• Female patients planning a pregnancy during the course of the study.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (5)

Medical University Hospital Innsbruck

Innsbruck, Tyrol, A-6020, Austria

Location

Knappschaftskrankenhaus Dortmund

Dortmund, North Rhine-Westphalia, 44309, Germany

Location

Orthopaedische Maatschap Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Results Point of Contact

• Title: Britta von den Brincken, Sr. Clinical Study Manager
• Organization: Stryker

britta.vondenbrincken@stryker.com

+491638999202

Study Officials

• Martin Krismer, Prof.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 17, 2015
• Study Start: May 18, 2009
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: February 22, 2024
• Results First Posted: June 14, 2021

Record last verified: 2024-02

Locations

DE (1); AU (1); NL (2); GB (1)