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

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ClinicalTrials.gov Identifier: NCT03382665
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Functional Deformities Pseudoarthrosis Revision of Endoprosthesis-treated Hips Fracture, Proximal Humeral Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies) Femur Fracture Pseudarthrosis Trochanteric Fractures Bridging of Large Bone Defects Revisions

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, Harris Hip Score, HOOS Score) and using documentation of sintering, wound healing and radiographic/clinical signs of loosening. 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 Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction
Actual Study Start Date : January 2010
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : December 2026



Primary Outcome Measures :
  1. Pain and walking ability determined by a Merle d' Aubigné Score increase of >4 points. [ Time Frame: 2 years (+/- 2 month) ]
    Pain and walking ability determined by a Merle d' Aubigné Score increase of >4 points compared to the pre-operative score points determined by the inclusion criteria of a Merle d' Aubigné < 12 points.

  2. 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.

  3. Patient satisfaction measured by the WOMAC Scores and decrease in min. 25 points. [ Time Frame: 2 years (+/- 2 month) ]
    Patient satisfaction measured by the WOMAC Scores and decrease in min. 25 points compared to the pre-operative determined points (WOMAC Score > 25 points pre-operative)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382665


Locations
Germany
Helios Klinik Hildesheim
Hildesheim, Germany, 31135
Klinikum Osnabrück GmbH
Osnabrück, Germany, 49076
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf, Germany, 92421
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Paola Vivoda Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03382665     History of Changes
Other Study ID Numbers: BMETEU.CR.EU79.10
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zimmer Biomet:
Revision total hip arthroplasty
Medical Device
Post Market Surveillance Study
Primary total hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Fractures, Bone
Necrosis
Femoral Fractures
Pseudarthrosis
Hip Fractures
Shoulder Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Pathologic Processes
Leg Injuries
Fractures, Ununited
Hip Injuries
Shoulder Injuries