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Pending Failure in Hard-hard Total Hip Arthroplasty (PF)

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ClinicalTrials.gov Identifier: NCT02427984
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Susanna Stea, Istituto Ortopedico Rizzoli

Brief Summary:

During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately 60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is very good, as widely demonstrated in the literature. On the basis of data produced by the only complete hip register in Italy that is run in our Lab (RIPO, Register of Orthopedic Implants in the Region Emilia-Romagna) survival rate of primary total hip prosthesis is 95.6% at 9 years. Reasons for revision are mainly aseptic loosening of one or both components (40% of the total) and dislocation (26%), being the latter much more frequent in the first two years. Less frequently revision is due to sepsis (7% of the total),bone fracture (11%), prosthesis fracture (3%) or pain (3%). Revision is relates, among the others, to prosthesis-related factors, such as fixation to bone and articular coupling. In our experience, during the last ten years 32% of implants had both articular component in ceramic , 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both components in metal.

Each solution has strengths and weakness and they have been identified and clinically applied in order to overcome step by step limitations observed in the previous one. The most recent are the hard-on-hard bearings, that is ceramic on ceramic and metal on metal. These two solutions, beside very promising results on wear resistance, show some peculiar failures: respectively fracture of the ceramic component and hypersensitivity induced by metal ions.

Aim of research proposal is to investigate two uncommon and less investigated early symptoms of failure:

  • 'noising hip' in ceramic on ceramic total hip arthroplasty
  • pain without radiographic signs of loosening in metal on metal total hip arthroplasty These two situations are extremely relevant, as they prelude to a failure of the prosthesis. If clearly identified they could represent a powerful tool in early diagnosis of pending failure To reach this goal our patients wearing hard-on-hard total hip arthroplasty, suffering for described symptoms will undergone a specific diagnostic procedure.

The first group will be studied through CT scan of the patients to evaluate impingement or instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be examined to identify ceramic wear debris, according to a method of separation and analysis in scanning electron microscopy that was set in our Lab.

Sound will be recorded by means of a wearable sensor set capable of recording the articular noise produced during level walking. This instrumentation will be coupled to motion analysis technology.

This would make possible a diagnostic approach able to correlate the involved factors to clinical occurrences, on the basis of the recorded frequencies.

-Second group will be studied through the dosage of circulating ions, deriving from the articular surfaces and through the histological classification of vasculitis in periimplant tissues. There is increasing evidence, indeed that locale release of submicron particles worn out from articular surfaces can release metal ions (mainly Chromium and Cobalt) responsible for lymphocyte local infiltration. In particular CD20 positive B lymphocyte and CD3 positive T lymphocyte and sometimes CD68 positive plasma cells are present. The cells could justify the development of pseudotumors in metal-on metal hip prosthesis.

Data collected from patients matched to in vitro results will allow us to to avoid or at least propose a more appropriate timing for revision surgery.


Condition or disease Intervention/treatment
Infection and Inflammatory Reaction Other: Metal ions dosage and evaluation of local/systemic reaction Other: Noise registration and metal ions determination Other: Metal ions dosage, evaluation of local/systemic reaction, noise registration

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Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Pending Failures of Total Hip Arthroplasty With Hard to Hard Bearings
Study Start Date : August 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Group/Cohort Intervention/treatment
Metal on Metal (MoM)
Patients wearing MoM hip prosthesis
Other: Metal ions dosage and evaluation of local/systemic reaction

Dosage of Chromium and Cobalt on several biological matrices deriving from each patients.

Determination of local/systemic reaction


Ceramic on Ceramic (CoC)
Patients wearing CoC hip prosthesis
Other: Noise registration and metal ions determination

Dosage of Vanadium and Titanium on several biological matrices deriving from each patients.

Determination of range of noise


Controls
Patients free from hip devices
Other: Metal ions dosage, evaluation of local/systemic reaction, noise registration

Dosage of Chromium, Cobalt, Vanadium and Titanium on several biological matrices deriving from each patients.

Determination of local/systemic reaction

Other Name: Controls comparison for variables considered




Primary Outcome Measures :
  1. Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l [ Time Frame: 3 years ]

    Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter.

    Will be counted the number of patients with level os metals above 7micrograms/liter

    This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals.


  2. Duration of Articular Noise Produced During Level Walking [ Time Frame: 3 years ]

    Measured by fast Fourier transform (FFT) expressed in duration (milliseconds)

    This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)


  3. Frequency of Articular Noise Produced During Level Walking [ Time Frame: 3 years ]
    Measured by fast Fourier transform (FFT) expressed in frequency (Hz) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)

  4. Amplitude of Articular Noise Produced During Level Walking [ Time Frame: 3 years ]
    Measured by fast Fourier transform (FFT) expressed in amplitude (decibel) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)


Secondary Outcome Measures :
  1. Number of Participants Who Scored Positive for ALVAL [ Time Frame: 3 years ]

    Histological score defined by the valuation of staining It was possible to valuate this outcome only for 29 out of 40 patients MoM (due to the availability of periprosthetic tissues).

    The arms CoC and controls were not studied for this issue because ALVAL could occur only in presence of Metals



Biospecimen Retention:   Samples With DNA
Whole blood, serum, synovial fluid, urines, periprosthetic tissues, at -80°C


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients (no septic) afferent to our ward and wearing hip prosthesis MoM or CoC. A group of control patients, waiting for primary total hip arthroplasty.
Criteria

Inclusion Criteria:

  • Patient waiting for primary total hip arthroplasty (THA)
  • Patients MoM and CoC referring to our ward
  • Informed consent approved
  • Questionnaire on habits filled

Exclusion Criteria:

  • Sepsis or suspected sepsis
  • Patients exposed to other font of metals

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): NCT02427984


Locations
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Italy
Laboratorio Tecnologia Medica
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Director: Aldo Toni, MD Istituto Ortopedico Rizzoli
Publications of Results:
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Responsible Party: Susanna Stea, M.sc., Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02427984    
Other Study ID Numbers: IORizzoli
First Posted: April 28, 2015    Key Record Dates
Results First Posted: May 25, 2016
Last Update Posted: May 25, 2016
Last Verified: April 2016
Keywords provided by Susanna Stea, Istituto Ortopedico Rizzoli:
Internal Left Hip Prosthesis
Internal Right Hip Prosthesis
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes