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

NCT03382665 | Terminated Results

• 1 other identifier: BMETEU.CR.EU79.10
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Revision total hip arthroplasty; Medical Device; Post Market Surveillance Study; Primary total hip arthroplasty

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Helios Klinik Hildesheim

Hildesheim, 31135, Germany

Location

Klinikum Osnabrück GmbH

Osnabrück, 49076, Germany

Location

Asklepios Orthopädische Klinik Lindenlohe

Schwandorf in Bayern, 92421, Germany

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Pseudarthrosis; Shoulder Fractures; Femoral Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Fractures, Ununited; Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Leg Injuries; Hip Injuries

Limitations and Caveats

Early termination of the study.

Results Point of Contact

• Title: Fabrizio Lucchini, Clinical Jr.Project Lead
• Organization: Zimmer Biomet

Fabrizio.Lucchini@zimmerbiomet.com

0041798575924

Study Officials

• Paola Vivoda

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: January 1, 2010
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 7, 2023
• Results First Posted: August 21, 2020

Record last verified: 2023-04

Locations

DE (3)