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Multicentre Observational Study Evaluating the Clinical Outcome of the H1 Ceramic Hip Resurfacing Arthroplasty (H1HRA)

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ClinicalTrials.gov Identifier: NCT03326804
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Embody Orthopaedic Limited

Brief Summary:

This is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety study followed by an efficacy study. Patients will be followed up for 10-years postoperatively.

The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the H1 device in terms of survivorship.

The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion release.The primary end point is revision for any reason.


Condition or disease Intervention/treatment
Hip Osteoarthritis Hip Disease Device: H1 Hip Resurfacing Arthroplasty

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Non-randomized, Consecutive Series, Multicentre, Observational Study to Evaluate the Clinical Outcome of ceramic-on- Ceramic Hip Resurfacing Arthroplasty Using the Ceramic, Non-porous, Non- Cemented H1 Hip Resurfacing Arthroplasty
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : September 25, 2027
Estimated Study Completion Date : September 25, 2027

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Cohort 1 - Safety

Cohort 1 will consist of the first 20 participants recruited into the study for H1 Hip Resurfacing Arthroplasty. These patients will receive additional CT scans preoperatively and then post-operatively at these time points: immediately postoperatively (2days), at 6 weeks, 3 months, 6 months, 1 year and 2 years. They will have metal-ion measurements for safety analysis. Blood samples will be taken preoperatively and postoperatively at 3 months, 6 months, 1 year and 2 years.

A safety analysis of Cohort 1 will be performed at the 6 week, 3 month and 6 month post-operative stage by independent assessors. Yearly clinical evaluations will be performed until 10 years, and radiographs at 3,5,10 years. If the investigation supports the safety of the implant, the study will proceed with recruitment into Cohort 2.

Device: H1 Hip Resurfacing Arthroplasty
A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device
Cohort 2 - Efficacy
Cohort 2 will consist of the remaining target size population of 230 patients for H1 Hip Resurfacing Arthroplasty. They will undergo the same intervention as previously described for Cohort 1, but will not undergo metal-ion testing and reduced frequency CT-scans.
Device: H1 Hip Resurfacing Arthroplasty
A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device



Primary Outcome Measures :
  1. Oxford Hip Score [ Time Frame: 10 years ]
    Hip Specific Patient Reported Outcome Measure (PROM)

  2. EQ-5D Health-Related Quality of Life Questionnaire [ Time Frame: 10 years ]
    Generic Patient Reported Outcome Measure (PROM)


Secondary Outcome Measures :
  1. Complication Rate [ Time Frame: 10 years ]
    Adverse Events and revisions

  2. Clinical objective outcome measures [ Time Frame: 10 years ]
    Harris Hip Score

  3. Acetabular Implant orientation [ Time Frame: 10 years ]
    Evaluation of AP and Lateral Hip Radiographs, measured in degrees

  4. Femoral Implant orientation [ Time Frame: 10 years ]
    Evaluation of AP and Lateral Hip Radiographs, measured in degrees

  5. Low-dose CT [ Time Frame: Up till 2 years ]
    CT to evaluate component migration and bone ingrowth (Safety study - Cohort 1 - 20 patients)

  6. Metal ion measurements [ Time Frame: Up till 2 years ]
    Concentration of metal ions in patient's blood (Safety study - Cohort 1 - 20 patients)


Biospecimen Retention:   Samples Without DNA
5 samples of 2ml of Blood stored in EDTA tubes will be taken and analysed for metal ion levels


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Indications for use of the H1 HRA in this investigation will be patients with end-stage hip disease who are candidates for primary hip arthroplasty using either a metal-on-metal hip resurfacing or a ceramic-on- ceramic THR. Typically they will be younger (<70 years) and active males and females with end-stage hip osteoarthritis, avascular necrosis of the femoral head, post-traumatic osteoarthritis or developmental dysplasia of the hip (DDH).
Criteria

Inclusion Criteria:

  • Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia)
  • Patient is eligible for hip resurfacing arthroplasty: i.e. has sufficient bone stock at the level of the femoral head (<1/3 necrosis of the head) and neck (not osteopenic/porotic, see exclusion criteria)
  • Patient is between 18 and 70 years old
  • Patient willing to comply with study requirements
  • Patient is legally entitled and able to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the informed consent form approved by the Ethics Committee.
  • Patient plans to be available through ten (10) years postoperative follow-up
  • Patient is able to understand the native language of the country of the trial centre

Exclusion Criteria:

  • Patient has a BMI greater than 40
  • Patient suffers from an active inflammatory joint disorder
  • Patient has an active infection or sepsis (treated or untreated)
  • Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head) or in general as in severe osteopenia or osteoporosis (Tscore < -2.5 as measured with BMD)
  • At the time of enrolment, patient has one or more of the following arthroplasties that have been
  • Implanted less than 6 months before the current hip arthroplasty:
  • Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
  • Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty
  • Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications.
  • Patient has a condition that may interfere with the hip arthroplasty survival or outcome (i.e. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
  • Patient has a known alcohol or drug abuse
  • Patient has an immunosuppressive disorder
  • Patient has a malignant tumour, metastatic, or neoplastic disease
  • Patient has severe comorbidities or a limited life expectancy
  • Patient lacks capacity to consent
  • Patient has an emotional or neurological condition that would pre-empt his/her ability or willingness to participate in the study
  • Patient is not willing or able to sign an informed consent form
  • Patient pregnant or breast feeding
  • Patient is not able or willing to come to follow-up visits
  • In addition, the following exclusion criteria are applied to the 20 patients (Cohort 1 and Cohort 1.1) in the safety study in whom metal ion measurements will be performed, since those conditions may be associated with elevated metal ion levels and could complicate the interpretation of the metal ion results:
  • Patients who already received another joint replacement, hip, knee, shoulder, ankle.
  • Workers in the paint, diamond, leather or other industries producing Co or Cr dust.
  • Patients taking medication, vitamins or food supplements containing Co or Cr and not able or willing to discontinue those.

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): NCT03326804


Contacts
Contact: Hardeep Johal 02033117326 h.johal@imperial.ac.uk

Locations
Belgium
ANCA Medical Centre Not yet recruiting
Deurle, Belgium
Contact: Hardeep Johal, BSc (Hons)       h.johal@imperial.ac.uk   
Principal Investigator: Koen de Smet, MD         
France
CHRU University Hospital Lille Not yet recruiting
Lille, France
Contact: Hardeep Johal, BSc (Hons)       h.johal@imperial.ac.uk   
Principal Investigator: Julien Girard, PhD         
Germany
University Hospital Carl Gustav Carus Not yet recruiting
Dresden, Germany
Contact: Hardeep Johal, BSc (Hons)       h.johal@imperial.ac.uk   
Principal Investigator: Klaus-Peter Günther, PhD         
United Kingdom
Charing Cross Hospital Recruiting
London, United Kingdom, W6 RF
Contact: Hardeep Johal, BSc (Hons)    020 33115216    h.johal@imperial.ac.uk   
Principal Investigator: Justin P Cobb, MD         
Kind Edward VII's Hospital Recruiting
London, United Kingdom
Contact: Hardeep Johal, BSc (Hons)       h.johal@imperial.ac.uk   
Principal Investigator: Sarah Muirhead-Allwood, FRCS         
Sponsors and Collaborators
Embody Orthopaedic Limited
Imperial College London
Investigators
Principal Investigator: Justin P Cobb, MD Imperial College London

Responsible Party: Embody Orthopaedic Limited
ClinicalTrials.gov Identifier: NCT03326804     History of Changes
Other Study ID Numbers: 213102
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Embody Orthopaedic Limited:
Hip Resurfacing Arthroplasty
Ceramic
H1

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases