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
NCT number | NCT03382665 |
Other study ID # | BMETEU.CR.EU79.10 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | March 2018 |
Verified date | April 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Helios Klinik Hildesheim | Hildesheim | |
Germany | Klinikum Osnabrück GmbH | Osnabrück | |
Germany | Asklepios Orthopädische Klinik Lindenlohe | Schwandorf In Bayern |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Germany,
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) |
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