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A Post Market Clinical Follow-up Study With the aneXys Cup

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ClinicalTrials.gov Identifier: NCT03274830
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mathys Ltd Bettlach

Brief Summary:
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Hip Device: aneXys

Detailed Description:

Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 150 patients in 3 clinics will be included. In each clinic 50 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.

Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post Market Clinical Follow-up Study With the aneXys Cup
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : April 2030

Group/Cohort Intervention/treatment
aneXys
cases with aneXys cup and Mathys hip stem
Device: aneXys
150 patients with the aneXys cup




Primary Outcome Measures :
  1. Cup migration after 2 years [ Time Frame: 2 years ]
    The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.


Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 10 years ]
    The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.

  2. Visual analogue scale vor pain [ Time Frame: 10 years ]
    The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.

  3. Visual analogue scale for satisfaction [ Time Frame: 10 years ]
    The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.

  4. The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 10 years ]
    The secondary endpoint will be the determination of the clinical outcome using the WOMAC.


Other Outcome Measures:
  1. Osteolysis [ Time Frame: 6-12 weeks - 10 years ]
    The first endpoint of interest is the occurrence of osteolysis around the cup.

  2. Lucent lines [ Time Frame: 6-12 weeks - 10 years ]
    The second endpoint of interest is the occurrence of lucent lines around the cup.

  3. Complications [ Time Frame: post-op - 10 years ]
    The first safety endpoint will be the number of complications with respect to the investigational product.

  4. Revisions [ Time Frame: post-op - 10 years ]
    The second safety endpoint will be the number revisions with respect to the investigational product.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
see eligibility criteria
Criteria

Inclusion Criteria:

  • Informed consent form (signed by participant and investigator)
  • Primary implantation
  • Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible.
  • Age at inclusion: between 18 and 75 years old
  • Willing to participate in the follow-up examinations
  • Complete recovery is expected

Exclusion Criteria:

  • Missing informed consent form (signed by participant and investigator)
  • Known or suspected non-compliance (e.g. drug or alcohol abuse)
  • Enrolment of the investigator, his/her family, employees and other dependent persons
  • Patients younger 18 years old
  • Revision surgery
  • Presence of sepsis or malignant tumours
  • ASA (American Society of Anesthesiologists) Classification >3
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274830


Contacts
Contact: Sandra Rosser, MSc +41 32 644 17 68 sandra.rosser@mathysmedical.com
Contact: Peter Münger, MPH +41 32 644 14 45 peter.muenger@mathysmedical.com

Locations
Germany
Marienstift Arnstadt Not yet recruiting
Arnstadt, Germany, 99310
Contact: Karsten Heubach, Dr. med.    +49 (36) 28 720 733    heubach@ms-arn.de   
Currently Defined Not yet recruiting
Berlin, Germany
Universitätsklinikum Leipzig
Leipzig, Germany, 04107
Sponsors and Collaborators
Mathys Ltd Bettlach
Investigators
Principal Investigator: Andreas Roth, Prof. Universitätsklinik Leipzig

Responsible Party: Mathys Ltd Bettlach
ClinicalTrials.gov Identifier: NCT03274830     History of Changes
Other Study ID Numbers: V01_06032017
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mathys Ltd Bettlach:
primary osteoarthritis
secondary osteoarthritis
femoral head fracture
necrosis