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CoreHip - Post Market Clinical Follow-Up Study

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ClinicalTrials.gov Identifier: NCT03685110
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:
The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.

Condition or disease Intervention/treatment
Degenerative Osteoarthritis Rheumatic Arthritis Fractures, Hip Necrosis, Femur Head Device: CoreHip Total Hip Arthroplasty

Detailed Description:
The CoreHip® System has a range of different stem designs to address most of the indications and anatomical conditions met in Primary THA patients within one implant and Instrument System.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-Interventional, Multicenter, Post-Market Clinical Follow-up Study CoreHip®
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026


Group/Cohort Intervention/treatment
CoreHip
Clinical and Radiological Data of 300 patients of a Standard Patient Population, who are treated with CoreHip Total Hip Arthroplasty for Indications according to the Instructions for Use (IfU) with a five year follow Up
Device: CoreHip Total Hip Arthroplasty
Replacement of the Hip Joint




Primary Outcome Measures :
  1. Change of Hip Joint Function measured by Harris Hip Score over time (HHS) [ Time Frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative ]

    The Harris Hip Score (HHS) assesses the results of hip surgery, evaluates various hip disabilities and methods of treatment in an adult population. The HHS is a clinician-based outcome measure. The domains covered are pain (pain severity and its effect on activities and need for pain medication), function (daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance)), absence of deformity, and range of Motion (hip flexion, adduction, internal rotation, and extremity length discrepancy).

    There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).



Secondary Outcome Measures :
  1. Restoration of preoperative leg length [ Time Frame: preoperative and 3 months postoperative ]
    Comparison of preoperative and postoperative leg length

  2. Restoration of preoperative offset [ Time Frame: preoperative and 3 months postoperative ]
    Comparison of preoperative and postoperative Offset angle of the femoral neck

  3. Change of Oxford Hip Score (OHS) over time [ Time Frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative ]
    A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement (THR) surgery. The score has a maximum of 48 points (best possible outcome), each question has five answers, ranging from 4 Points (best possible) to 0 Points (worst possible).

  4. Change of Quality of Life (EQ-5D-5L) over time [ Time Frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative ]
    EuroQol five-dimension scale. A standardised instrument created by the EuroQol Group as a measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five Levels reflecting severity (no problems, slight problems, moderate problems, severe problems and extreme Problems). Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  5. Change of Radiological results: implant position [ Time Frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative ]
    Changes in implant Position throughout the follow-up period

  6. Development of Radiological results: radiolucent lines [ Time Frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative ]
    Development of radiolucent lines ("Gruen" zones) in AP and lateral x-rays throughout the follow-up period

  7. Adverse Events [ Time Frame: up to five years ]
    documentation of all product related adverse Events occuring with the Hip Prosthesis throughout the follow-up period

  8. Survival Rate of the Hip Prosthesis [ Time Frame: up to five years ]
    Survival Analysis of stems in-situ throughout the follow-up period



Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
adult patients
Criteria

Inclusion Criteria:

  • Patient age ≥ 18 years
  • Indication for THA with a CoreHip® stem
  • Written informed consent

Exclusion Criteria:

  • Pregnancy
  • Patient age < 18 years
  • Patient not able to regularly participate at the follow-up examinations

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): NCT03685110


Contacts
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Contact: Anne-Katrin Wacker +49-7461-95-1509 anne_katrin.wacker@bbraun.com
Contact: Andrea Weiler, Dr. +49-7461-95-2721 andrea.weiler@aesculap.de

Locations
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Germany
Ortrhopädische Klinik Markgröningen Recruiting
Markgröningen, Baden-Württemberg, Germany, 71706
Contact: Bernd Fink, Prof. Dr. med.         
Principal Investigator: Bernd Fink, Prof.         
Orthopädische Chirurgie München Recruiting
München, Bayern, Germany, 81369
Contact: Robert Hube, Prof. Dr. med.         
Principal Investigator: Robert Hube, Prof.         
MHH Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Henning Windhagen, Prof. Dr. med.         
Principal Investigator: Henning Windhagen, Prof. Dr. med.         
Sub-Investigator: Thilo Flörkemeyer, PD Dr. med.         
Switzerland
Spital Brig Not yet recruiting
Brig, Switzerland, 3902
Contact: Andreas Ottersbach, Dr. med.         
Principal Investigator: Andreas Ottersbach, Dr. med.         
Luzerner Kantonsspital Sursee Not yet recruiting
Sursee, Switzerland, 6210
Contact: Jens Decking, PD Dr. med.         
Principal Investigator: Jens Decking, PD Dr. med.         
Sponsors and Collaborators
Aesculap AG
Investigators
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Principal Investigator: Henning Windhagen, Prof. Dr. med. Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover

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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT03685110     History of Changes
Other Study ID Numbers: AAG-O-H-1509
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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

Keywords provided by Aesculap AG:
Hip Arthroplasty
Hip Prosthesis

Additional relevant MeSH terms:
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Streptococcal Infections
Osteoarthritis
Necrosis
Rheumatic Fever
Hip Fractures
Femur Head Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Osteonecrosis
Bone Diseases