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

Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Germany
  • Hildesheim, Germany, 31135
    • Helios Klinik Hildesheim
  • Osnabrück, Germany, 49076
    • Klinikum Osnabrück GmbH
  • Schwandorf In Bayern, Germany, 92421
    • Asklepios Orthopädische Klinik Lindenlohe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.	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.	baseline/Pre-op and 2 years (+/- 2 months)
Implant Survival Measured by the Number of Revisions.	Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.	2 years (+/- 2 month)
WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value	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	baseline/Pre-op and 2 years (+/- 2 months)

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Medical Device; Post Market Surveillance Study; Primary total hip arthroplasty; Revision total hip arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Shoulder Injuries; Hip Injuries; Fractures, Ununited; Femoral Fractures; Necrosis; Fractures, Bone; Hip Fractures; Shoulder Fractures; Pseudarthrosis
• Other Study ID Numbers: BMETEU.CR.EU79.10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No