Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Study Details
Study Description
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 Design
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helios Klinik Hildesheim | Hildesheim | Germany | 31135 | |
| 2 | Klinikum Osnabrück GmbH | Osnabrück | Germany | 49076 | |
| 3 | Asklepios Orthopädische Klinik Lindenlohe | Schwandorf In Bayern | Germany | 92421 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Study Director: Paola Vivoda, Zimmer Biomet
Study Documents (Full-Text)
More Information
Publications
None provided.- BMETEU.CR.EU79.10
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Arm/Group Description | Patients in need of a total hip arthroplasty |
| Period Title: Overall Study | |
| STARTED | 70 |
| Actual Enrollment | 59 |
| 5 Year Follow up | 25 |
| COMPLETED | 25 |
| NOT COMPLETED | 45 |
Baseline Characteristics
| Arm/Group Title | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Arm/Group Description | Patients in need of a total hip arthroplasty |
| Overall Participants | 61 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
72.1
(8.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
35
57.4%
|
| Male |
26
42.6%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| Germany |
61
100%
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
28.9
(5.5)
|
| Operative Side (Count of Participants) | |
| LEFT |
28
45.9%
|
| RIGHT |
31
50.8%
|
Outcome Measures
| Title | Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. |
|---|---|
| Description | 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. |
| Time Frame | baseline/Pre-op and 2 years (+/- 2 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| MdA score not available for all participants |
| Arm/Group Title | Patients, Suffering From Severe Hip Pain and Disability | Patients, Suffering From Severe Hip Pain and Disability 1 |
|---|---|---|
| Arm/Group Description | Preop MdA scores | 2-year MdA scores |
| Measure Participants | 54 | 35 |
| Mean (Standard Deviation) [score on a scale] |
6.3
(3.7)
|
13.8
(2.8)
|
| Title | Implant Survival Measured by the Number of Revisions. |
|---|---|
| Description | Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method. |
| Time Frame | 2 years (+/- 2 month) |
Outcome Measure Data
| Analysis Population Description |
|---|
| number of revisions at 2 years |
| Arm/Group Title | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Arm/Group Description | Patients in need of a total hip arthroplasty |
| Measure Participants | 39 |
| Measure implants | 39 |
| Count of Units [implants] |
11
|
| Title | WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value |
|---|---|
| Description | 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 |
| Time Frame | baseline/Pre-op and 2 years (+/- 2 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Patients, Suffering From Severe Hip Pain and Disability 1 | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|---|
| Arm/Group Description | Preop Total WOMAC scores | 2-year Total WOMAC scores |
| Measure Participants | 41 | 26 |
| Mean (Standard Deviation) [score on a scale] |
66.8
(22.4)
|
27.5
(20.9)
|
Adverse Events
| Time Frame | Adverse events were collected for the entire duration of the study, from first surgery to last follow up at 5 years. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Patients, Suffering From Severe Hip Pain and Disability | |
| Arm/Group Description | Patients in need of a total hip arthroplasty | |
All Cause Mortality |
||
| Patients, Suffering From Severe Hip Pain and Disability | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/70 (11.4%) | |
Serious Adverse Events |
||
| Patients, Suffering From Severe Hip Pain and Disability | ||
| Affected / at Risk (%) | # Events | |
| Total | 38/70 (54.3%) | |
| General disorders | ||
| General SAE | 38/70 (54.3%) | 38 |
Other (Not Including Serious) Adverse Events |
||
| Patients, Suffering From Severe Hip Pain and Disability | ||
| Affected / at Risk (%) | # Events | |
| Total | 33/70 (47.1%) | |
| General disorders | ||
| General AE | 33/70 (47.1%) | 33 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Fabrizio Lucchini, Clinical Jr.Project Lead |
|---|---|
| Organization | Zimmer Biomet |
| Phone | 0041798575924 |
| Fabrizio.Lucchini@zimmerbiomet.com |
- BMETEU.CR.EU79.10