An observational study in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Terminated at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Zimmer Biomet · 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.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 601 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Indications for primary hip replacement:
Revision THA:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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
Time frame: baseline/Pre-op and 2 years (+/- 2 months)
| Milestone | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Started | 70 |
| Actual enrollment | 59 |
| 5 year follow up | 25 |
| Completed | 25 |
| Not completed | 45 |
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.
| score on a scale | Patients, Suffering From Severe Hip Pain and Disability | Patients, Suffering From Severe Hip Pain and Disability 1 |
|---|---|---|
| Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. | 6.3 ± 3.7 | 13.8 ± 2.8 |
Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.
| implants | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Implant Survival Measured by the Number of Revisions. | 11 |
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
| score on a scale | Patients, Suffering From Severe Hip Pain and Disability 1 | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|---|
| WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value | 66.8 ± 22.4 | 27.5 ± 20.9 |
Collected over Adverse events were collected for the entire duration of the study, from first surgery to last follow up at 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients, Suffering From Severe Hip Pain and Disability | 8/70 (11.4%) | 38/70 (54.3%) | 33/70 (47.1%) |
| Event | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| General SAEGeneral disorders | 38/70 |
| Event | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| General AEGeneral disorders | 33/70 |
| Age, Continuous(years) | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Mean | 72.1 ± 8.8 |
| Sex: Female, Male(Participants) | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Female | 35 |
| Male | 26 |
| Race and Ethnicity Not Collected(Participants) | Patients, Suffering From Severe Hip Pain and Disability |
|---|
| Region of Enrollment(participants) | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Germany | 61 |
| BMI(kg/m^2) | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| Mean | 28.9 ± 5.5 |
| Operative Side(Participants) | Patients, Suffering From Severe Hip Pain and Disability |
|---|---|
| LEFT | 28 |
| RIGHT | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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