Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorin

About this trial

This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Man or woman >18 years

Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study

Subjects who agreed for study participation.

Disqualifiers

Subjects with existing tumour and/or particularly high surgical risk-

Subjects with anaesthetic risk class IV or higher

Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)

Contraindications for arthroplasty with a Corin hip devices as per product IFU

Trial population

Cohort of patients with a partial or total hip replacement (Corin implants)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 1 trial group
Group A: Patients with Hip arthroplasty

Trial outcomes

Primary outcomes

1

Evaluation of long-term outcome after hip arthroplasty with Corin implants.

Implants revision rate at 10-year FU hip arthroplasty

Time frame
At 10 years

Secondary outcomes

1

Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.

Implants revision rate at 15- and 20-year FU.

Time frame
at 15- and 20-year
2

Evaluation of clinical performance of Corin hip implants

Change of Patient Reported Outcome Measures (PROMs)

Time frame
starting intraoperatively up to 20-year FU
3

Evaluation of Safety of Corin hip implants

Number, severity and causal relationship of procedure or implant-related Adverse Events

Time frame
starting intraoperatively up to 20-year FU
4

Radiological evaluation of positioning and osteointegration of Corin hip implants.

Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation

Time frame
starting intraoperatively up to 20-year FU

Other outcomes

Sponsors and contacts

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