Pending Failure in Hard-hard Total Hip Arthroplasty

NCT02427984 | Completed Results DMC

• 1 other identifier: IORizzoli
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection and Inflammatory Reaction

Keywords

Internal Left Hip Prosthesis; Internal Right Hip Prosthesis

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l

  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.

  3 years

• Duration of Articular Noise Produced During Level Walking

  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 years

• Frequency of Articular Noise Produced During Level Walking

  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)

  3 years

• Amplitude of Articular Noise Produced During Level Walking

  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)

  3 years

Secondary Outcomes (1)

• Number of Participants Who Scored Positive for ALVAL

  3 years

Study Arms (3)

Metal on Metal (MoM)

Patients wearing MoM hip prosthesis

Other: Metal ions dosage and evaluation of local/systemic reaction

Ceramic on Ceramic (CoC)

Patients wearing CoC hip prosthesis

Other: Noise registration and metal ions determination

Controls

Patients free from hip devices

Other: Metal ions dosage, evaluation of local/systemic reaction, noise registration

Interventions

Metal ions dosage and evaluation of local/systemic reaction OTHER

Dosage of Chromium and Cobalt on several biological matrices deriving from each patients. Determination of local/systemic reaction

Metal on Metal (MoM)

Noise registration and metal ions determination OTHER

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

Ceramic on Ceramic (CoC)

Metal ions dosage, evaluation of local/systemic reaction, noise registration OTHER

Dosage of Chromium, Cobalt, Vanadium and Titanium on several biological matrices deriving from each patients. Determination of local/systemic reaction

Also known as: Controls comparison for variables considered

Controls

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Laboratorio Tecnologia Medica

Bologna, Italy, 40136, Italy

Location

Related Publications (4)

• Beraudi A, Stea S, De Pasquale D, Bordini B, Catalani S, Apostoli P, Toni A. Metal ion release: also a concern for ceramic-on-ceramic couplings? Hip Int. 2014 Jul-Aug;24(4):321-6. doi: 10.5301/hipint.5000132. Epub 2014 Mar 24.

  PMID: 24817392 RESULT

• Beraudi A, Catalani S, Montesi M, Stea S, Sudanese A, Apostoli P, Toni A. Detection of cobalt in synovial fluid from metal-on-metal hip prosthesis: correlation with the ion haematic level. Biomarkers. 2013 Dec;18(8):699-705. doi: 10.3109/1354750X.2013.846413. Epub 2013 Oct 17.

  PMID: 24134776 RESULT

• Catalani S, Stea S, Beraudi A, Gilberti ME, Bordini B, Toni A, Apostoli P. Vanadium release in whole blood, serum and urine of patients implanted with a titanium alloy hip prosthesis. Clin Toxicol (Phila). 2013 Aug;51(7):550-6. doi: 10.3109/15563650.2013.818682. Epub 2013 Jul 11.

  PMID: 23845123 RESULT

• De Pasquale D, Stea S, Beraudi A, Montesi M, Squarzoni S, Toni A. Ceramic debris in hip prosthesis: correlation between synovial fluid and joint capsule. J Arthroplasty. 2013 May;28(5):838-41. doi: 10.1016/j.arth.2013.01.019. Epub 2013 Mar 13.

  PMID: 23489725 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, synovial fluid, urines, periprosthetic tissues, at -80°C

MeSH Terms

Conditions

Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Susanna Stea
• Organization: Medical technology laboratory, Rizzoli Orthopaedic Institute

stea@tecno.ior.it

00390516366861

Study Officials

• Aldo Toni, MD

  Istituto Ortopedico Rizzoli

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.sc.

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: April 28, 2015
• Study Start: August 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 25, 2016
• Results First Posted: May 25, 2016

Record last verified: 2016-04

Locations

IT (1)