Clinical trial NCT02427984: Pending Failure in Hard-hard Total Hip Arthroplasty
Official title: Early Diagnosis of Pending Failures of Total Hip Arthroplasty With Hard to Hard Bearings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection and Inflammatory Reaction
Keywords: Internal Left Hip Prosthesis
Internal Right Hip Prosthesis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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 clinical experience and 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 http://ripo.cineca.it) 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 can be related, among the others, to prosthesis-linked factors, such as fixation to bone and articular coupling.

In the experience of RIPO, 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.

Alumina ceramic-on-ceramic (COC) bearings have been shown to produce substantially less wear debris than traditional metal/ceramic on polyethylene bearings. In addition, the alumina ceramic material itself is essentially bioinert in both bulk and particulate form . Unlike metal-on-metal bearings (MOM), this bearing couple does not release metal ions into the body either from the articulation or from breakdown of wear debris. Weakness of ceramic-on-ceramic bearings are represented by brittleness of the material. Ceramic can fracture, even in very few cases, due to trauma or to malpositioning. Beside this occurrence of noise during gait of patients can be extremely disturbing for patient itself, leading to request of revision. These two solutions represent more recent proposal that technology suggested to overcome problem of wear.

Hard components on plastic has the unsolved problem of wear debris, leading to osteolysis and consequent failure of he im plant. The problem has only partially solved by the introduction of cross linked polyethylene, aimed to improve tribological behaviour of the plastic.

Rizzoli Institute is the only public mono-specialistic research hospital in Italy. Nearly 500 hip prosthesis revisions are performed here every year in the structure. Due to its high specialization difficult cases from all the country are treated here, not on ly when anatomy of the patient is damaged (dislocation of the hip, post traumatic arthritis) but .even more frequently when failure of the implant occurred.

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 in metal on metal total hip arthroplasty Even if not numerically so important, 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.

The first point 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, so as to provide a temporal correlation between the recorded noise and the gait cycle. It will be developed in the first phase of the project. In parallel surface analyses will be conducted on retrievals that are stored in the Lab since 2000, in one of the biggest retrieval study ever conducted in our country. Type of damage, surface roughness of both ceramic components will be analysed and compared to clinical data.

Finally the study will be completed in vitro, using an hip simulator, to reproduce the possible clinical scenarios leading to hip noise, record, and analyse it in a reproducible and robust manner. This would make possible a diagnostic approach able to correlate the involved factors to clinical occurrences, on the basis of the recorded frequencies. Second point 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 cluster of differentiation antigen 20 (CD20) positive B lymphocyte and cluster of differentiation 3 (CD3) positive T lymphocyte and sometimes cluster of differentiation antigen 68 (CD68) positive plasma cells are present. The cells could indicate a specific phlogistic condition responsible for pain and eventually subsequent revision.

Data collected on studied population will allow a better understanding of the two phenomena and possibly will suggest new therapeutic approaches to the problems.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l
timeFrame: 3 years
measure: Duration of Articular Noise Produced During Level Walking
timeFrame: 3 years
measure: Frequency of Articular Noise Produced During Level Walking
timeFrame: 3 years
measure: Amplitude of Articular Noise Produced During Level Walking
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants Who Scored Positive for ALVAL
timeFrame: 3 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Laboratorio Tecnologia Medica
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Aldo Toni, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.