Clinical trial NCT03685110: CoreHip - Post Market Clinical Follow-Up Study
Official title: Prospective, Non-Interventional, Multicenter, Post-Market Clinical Follow-up Study CoreHip®
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Degenerative Osteoarthritis
Rheumatic Arthritis
Fractures, Hip
Necrosis, Femur Head
Keywords: Hip Arthroplasty
Hip Prosthesis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.

Detailed description: The CoreHip® System has a range of different stem designs to address most of the indications and anatomical conditions met in Primary THA patients within one implant and Instrument System.

Eligibility criteria: Inclusion Criteria:

* Patient age ≥ 18 years
* Indication for THA with a CoreHip® stem
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Patient age \< 18 years
* Patient not able to regularly participate at the follow-up examinations

Primary outcomes:
measure: Change of Hip Joint Function measured by Harris Hip Score over time (HHS)
timeFrame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary outcomes:
measure: Restoration of preoperative leg length
timeFrame: preoperative and 3 months postoperative
measure: Restoration of preoperative offset
timeFrame: preoperative and 3 months postoperative
measure: Change of Oxford Hip Score (OHS) over time
timeFrame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
measure: Change of Quality of Life (EQ-5D-5L) over time
timeFrame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
measure: Change of Radiological results: implant position
timeFrame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
measure: Development of Radiological results: radiolucent lines
timeFrame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
measure: Adverse Events
timeFrame: up to five years
measure: Survival Rate of the Hip Prosthesis
timeFrame: up to five years
Other outcomes:
Locations:
city: Markgröningen
country: Germany
facility: Ortrhopädische Klinik Markgröningen
state: Baden-Württemberg
city: München
country: Germany
facility: Orthopädische Chirurgie München
state: Bayern
city: Hannover
country: Germany
facility: MHH
state: Niedersachsen
city: Salzkotten
country: Germany
facility: St. Josefs Krankenhaus Endoprothetik Zentrum
city: Brig
country: Switzerland
facility: Spital Brig
city: Sursee
country: Switzerland
facility: Luzerner Kantonsspital Sursee
Study officials:
affiliation: Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover
name: Henning Windhagen, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: