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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03382665
• Other study ID #: BMETEU.CR.EU79.10
• Status: Terminated
• Start date: January 2010
• Est. completion date: March 2018

Study information

• Verified date: April 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: March 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Helios Klinik Hildesheim	Hildesheim
Germany	Klinikum Osnabrück GmbH	Osnabrück
Germany	Asklepios Orthopädische Klinik Lindenlohe	Schwandorf In Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)