Trial Outcomes & Findings for Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction (NCT NCT03382665)

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

70 participants

Primary outcome timeframe

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

Results posted on

2023-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Patients, Suffering From Severe Hip Pain and Disability Patients in need of a total hip arthroplasty
Overall Study STARTED	70
Overall Study Actual Enrollment	59
Overall Study 5 Year Follow up	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data available for 57 Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients, Suffering From Severe Hip Pain and Disability n=61 Participants Patients in need of a total hip arthroplasty
Age, Continuous	72.1 years STANDARD_DEVIATION 8.8 • n=57 Participants • Data available for 57 Patients
Sex: Female, Male Female	35 Participants n=61 Participants
Sex: Female, Male Male	26 Participants n=61 Participants
Region of Enrollment Germany	61 participants n=61 Participants
BMI	28.9 kg/m^2 STANDARD_DEVIATION 5.5 • n=56 Participants • BMI available for 56 patients
Operative Side LEFT	28 Participants n=59 Participants • Data on operative side available for 59 patients
Operative Side RIGHT	31 Participants n=59 Participants • Data on operative side available for 59 patients

PRIMARY outcome

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

Population: MdA score not available for all participants

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.

Outcome measures

Outcome measures
Measure	Patients, Suffering From Severe Hip Pain and Disability n=54 Participants Preop MdA scores	Patients, Suffering From Severe Hip Pain and Disability 1 n=35 Participants 2-year MdA scores
Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.	6.3 score on a scale Standard Deviation 3.7	13.8 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: 2 years (+/- 2 month)

Population: number of revisions at 2 years

Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method.

Outcome measures

Outcome measures
Measure	Patients, Suffering From Severe Hip Pain and Disability n=39 implants Preop MdA scores	Patients, Suffering From Severe Hip Pain and Disability 1 2-year MdA scores
Implant Survival Measured by the Number of Revisions.	11 implants	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients, Suffering From Severe Hip Pain and Disability n=41 Participants Preop MdA scores	Patients, Suffering From Severe Hip Pain and Disability 1 n=26 Participants 2-year MdA scores
WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value	66.8 score on a scale Standard Deviation 22.4	27.5 score on a scale Standard Deviation 20.9

Adverse Events

Patients, Suffering From Severe Hip Pain and Disability

Serious events: 38 serious events

Other events: 33 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Patients, Suffering From Severe Hip Pain and Disability n=70 participants at risk Patients in need of a total hip arthroplasty
General disorders General SAE	54.3% 38/70 • Number of events 38 • Adverse events were collected for the entire duration of the study, from first surgery to last follow up at 5 years.

Other adverse events

Other adverse events
Measure	Patients, Suffering From Severe Hip Pain and Disability n=70 participants at risk Patients in need of a total hip arthroplasty
General disorders General AE	47.1% 33/70 • Number of events 33 • Adverse events were collected for the entire duration of the study, from first surgery to last follow up at 5 years.

Additional Information

Fabrizio Lucchini, Clinical Jr.Project Lead

Zimmer Biomet

Phone: 0041798575924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60