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

Terminated

• Conditions: Osteoarthritis; Avascular Necrosis; Femur Fracture; Pseudoarthrosis; Revisions; Revision of Endoprosthesis-treated Hips; Fracture, Proximal Humeral; Trochanteric Fractures; Bridging of Large Bone Defects; Rheumatoid Arthritis

• Registration Number: NCT03382665
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2017-08
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Completion: 2018-03
• Results First Submitted: 2020-04-30
• Results First Submitted QC: 2020-08-10
• Results First Posted: 2020-08-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survival Measured by the Number of Revisions.	2 years (+/- 2 month)	Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.
Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.	baseline/Pre-op and 2 years (+/- 2 months)	Pain and walking ability determined by a Merle d' Aubigné Score (MdA) increase of \>4 points compared to the pre-operative score points.; The patients were evaluated by the Merle d'Aubigné hip score, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The value of each item is summed to a total score. The total minimum score reached is 3, and the maximum is 18. Higher scores mean a better outcome.
WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value	baseline/Pre-op and 2 years (+/- 2 months)	at 2-years post op, WOMAC score (Western Ontario and McMaster Universities Arthritis Index) has to be at least 25 points lower compared to preop values; Scale: min 0-Max 100; Higher values mean worse outcome

Trial Locations

Locations (3)

Helios Klinik Hildesheim; 🇩🇪 Hildesheim, Germany

Klinikum Osnabrück GmbH; 🇩🇪 Osnabrück, Germany

Asklepios Orthopädische Klinik Lindenlohe; 🇩🇪 Schwandorf In Bayern, Germany