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

An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 3 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
How many people: 70 participants
Where: 3 sitesGermany
Study dates: Jan 2010to Mar 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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:

Show all 15Show fewer

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

Helios Klinik Hildesheim
Hildesheim, 31135
Klinikum Osnabrück GmbH
Osnabrück, 49076
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf in Bayern, 92421

Other trials in Germany

About this study

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

Read the 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.

Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities, Pseudoarthrosis, Revision of Endoprosthesis-treated Hips
Keywords: Revision total hip arthroplasty, Medical Device, Post Market Surveillance Study, Primary total hip arthroplasty
Medical subject headings: Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Pseudarthrosis, Shoulder Fractures, Femoral Fractures, Hip Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: baseline/Pre-op and 2 years (+/- 2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Mar 2018

First posted26 Dec 2017
Study startJan 2010
Primary completionAug 2017
Study completionMar 2018

Why it stopped: CE mark will not be renewed, PMCF data no longer required

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03382665
Sponsor's protocol ID: BMETEU.CR.EU79.10
Status last verified: Apr 2023
First submitted: 19 Dec 2017
Last updated: 7 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction
ClinicalTrials.gov ID: NCT03382665
Acronym / sponsor ID: BMETEU.CR.EU79.10
Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities, Pseudoarthrosis, Revision of Endoprosthesis-treated Hips
Keywords: Revision total hip arthroplasty, Medical Device, Post Market Surveillance Study, Primary total hip arthroplasty
Study type: Observational
Recruitment status: TerminatedReason stopped: CE mark will not be renewed, PMCF data no longer required
Enrolment: 70 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Jan 2010 (actual)
Primary completion: Aug 2017 (actual)
Study completion: Mar 2018 (actual)
First posted: 26 Dec 2017 (actual)
Results: Posted 21 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (15 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.
Time frame: 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.
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 21 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients, Suffering From Severe Hip Pain and Disability	70	25

Primary outcome: Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.

Time frame: baseline/Pre-op and 2 years (+/- 2 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Patients, Suffering From Severe Hip Pain and Disability n = 54	Patients, Suffering From Severe Hip Pain and Disability 1 n = 35
Value	6.3 (3.7)	13.8 (2.8)

Population analysed: MdA score not available for all participants

Primary outcome: Implant Survival Measured by the Number of Revisions.

Time frame: 2 years (+/- 2 month). Count of units. Unit: implants

Measure	Patients, Suffering From Severe Hip Pain and Disability n = 39
Value	11

Population analysed: number of revisions at 2 years

Primary outcome: WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value

Time frame: baseline/Pre-op and 2 years (+/- 2 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Patients, Suffering From Severe Hip Pain and Disability 1 n = 41	Patients, Suffering From Severe Hip Pain and Disability n = 26
Value	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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients, Suffering From Severe Hip Pain and Disability	38 of 70 (54.3%)	33 of 70 (47.1%)	8 of 70

Limitations and caveats (from the sponsor): Early termination of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paola Vivoda study director

Zimmer Biomet

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points. (time frame: baseline/Pre-op and 2 years (+/- 2 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03382665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.