Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction

Zimmer Biomet

Status: Terminated

Conditions: Revision of Endoprosthesis-treated Hips; Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies); Bridging of Large Bone Defects; Functional Deformities; Osteoarthritis; Femur Fracture; Revisions; Trochanteric Fractures; Pseudarthrosis; Fracture, Proximal Humeral; Pseudoarthrosis; Avascular Necrosis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03382665

BMETEU.CR.EU79.10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design