Clinical trial NCT03382665: Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Official title: Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Functional Deformities
Pseudoarthrosis
Revision of Endoprosthesis-treated Hips
Fracture, Proximal Humeral
Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies)
Femur Fracture
Pseudarthrosis
Trochanteric Fractures
Bridging of Large Bone Defects
Revisions
Keywords: Revision total hip arthroplasty
Medical Device
Post Market Surveillance Study
Primary total hip arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Because of the studiesindications it is assumed that patients have a relatively high (\> 60 Jahre) age at the time of their operations. Therefore a higher letality and a higher drop-out-rate is expected compared to study populations of primary hip replacement. To reach the necessery power for this clinical study at least 70 patients should be recruited.

Brief summary: The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and revision total hip arthroplasty.

Detailed description: This multi-center, prospective, non-controlled, consecutive cohort post market surveillance study will serve the purpose of confirming long-term safety and performance of the Hyperion® system. The performance of the Hyperion® THA System will be evaluated using standard scoring systems (Merle d'Aubigné Score, HOOS Score). Safety will be evaluated by adverse event reporting.

The study will be performed at 6 sites, enrolling in total 70 patients. Follow-up visits are planned after 3 to 6 month, 1, 2 and 5 years. The scores will be filled in pre-operatively and post-operatively until 5 years. In order to obtain mid- to long-term patient satisfaction data the patient questionnaire will be send to the patient at 7 and 10 years, additionally. Xrays will be done pre-operatively, immediate post-operatively and at each of the Follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Patient age at least 18 years
* Fully conscious and capable patients
* Signed informed consent
* Stationary treatment
* Merle d'Aubigné \< 12 Points, WOMAC Score \> 25 Points
* Patients with at least one of the following indications:

Indications for primary hip replacement:

* Non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis (head necrosis)
* Rheumatoid arthritis
* Functional deformities
* Provision of non-endoprosthetic previous operations of the hip joint (e.g., transposition osteotomies)
* Treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as fractures of the proximal femur affecting the head, which can not be treated by other techniques

Revision THA:

* Revision of endoprosthesis-treated hips as a result of septic or aseptic loosening, sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis)
* Bridging of large bone defects (precondition: suitable proximal bone situation for a stable anchorage), i.e. for tumors

Exclusion Criteria:

* Infections
* Patients under 18 years
* Pregnant or breastfeeding patients
* Known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day for men) or drug abuse
* Legal incapacity or restricted capacity
* Participation in another clinical trial within the last 30 days or planned participation in another clinical trial within the next 3 months
* Patients who are unable to attend to follow-up

Primary outcomes:
measure: Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.
timeFrame: baseline/Pre-op and 2 years (+/- 2 months)
measure: Implant Survival Measured by the Number of Revisions.
timeFrame: 2 years (+/- 2 month)
measure: WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value
timeFrame: baseline/Pre-op and 2 years (+/- 2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Hildesheim
country: Germany
facility: Helios Klinik Hildesheim
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
city: Schwandorf In Bayern
country: Germany
facility: Asklepios Orthopädische Klinik Lindenlohe
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References: