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

N/AActive Not RecruitingNCT03274830

Mathys Ltd Bettlach102 enrolled

Overview

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.

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 100 patients in 3 clinics will be included. In each clinic 10-57 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

Enrollment

102

Conditions

Arthroplasty, Replacement, Hip

Interventions

aneXysDEVICE

150 patients with the aneXys cup

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

DRK Kliniken Berlin | Köpernick

Berlin, Germany

DRK Kliniken Berlin | Westend

Berlin, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

Cup migration after 2 years

The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.

Time frame: 2 years

Secondary Outcomes

Harris Hip Score

The secondary endpoint will be the determination of the clinical outcome using the Harris Hip Score.

Time frame: 10 years

Visual analogue scale vor pain

The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for pain.

Time frame: 10 years

Visual analogue scale for satisfaction

The secondary endpoint will be the determination of the clinical outcome using the Visual analogue scale for satisfaction.

Time frame: 10 years

The Western Ontario and McMaster Universities Osteoarthritis Index

The secondary endpoint will be the determination of the clinical outcome using the WOMAC.

Time frame: 10 years

Data from ClinicalTrials.gov

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