Clinical trial NCT03274830: A Post Market Clinical Follow-up Study With the aneXys Cup
Official title: A Post Market Clinical Follow-up Study With the aneXys Cup
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthroplasty, Replacement, Hip
Keywords: primary osteoarthritis
secondary osteoarthritis
femoral head fracture
necrosis
Lead sponsor: Mathys Ltd Bettlach
Sponsor class: INDUSTRY
First posted: 2017-09-07
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: see eligibility criteria

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Cup migration after 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 10 years
measure: Visual analogue scale vor pain
timeFrame: 10 years
measure: Visual analogue scale for satisfaction
timeFrame: 10 years
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 10 years
Other outcomes:
measure: Osteolysis
timeFrame: 6-12 weeks - 10 years
measure: Lucent lines
timeFrame: 6-12 weeks - 10 years
measure: Complications
timeFrame: post-op - 10 years
measure: Revisions
timeFrame: post-op - 10 years
Locations:
city: Berlin
country: Germany
facility: DRK Kliniken Berlin | Köpernick
city: Berlin
country: Germany
facility: DRK Kliniken Berlin | Westend
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
Study officials:
affiliation: Universitätsklinik Leipzig
name: Andreas Roth, Prof.
role: PRINCIPAL_INVESTIGATOR
References: