PF: Pending Failure in Hard-hard Total Hip Arthroplasty
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l [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.
- Duration of Articular Noise Produced During Level Walking [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)
- Frequency of Articular Noise Produced During Level Walking [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)
- Amplitude of Articular Noise Produced During Level Walking [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
- Number of Participants Who Scored Positive for ALVAL [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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratorio Tecnologia Medica | Bologna | Italy | 40136 |
Sponsors and Collaborators
- Istituto Ortopedico Rizzoli
Investigators
- Study Director: Aldo Toni, MD, Istituto Ortopedico Rizzoli
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IORizzoli
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Metal on Metal (MoM) | Controls | Ceramic on Ceramic (CoC) |
|---|---|---|---|
| Arm/Group Description | All the patients of our Division with MoM THA | All the patients of our Division with CoC THA | |
| Period Title: Overall Study | |||
| STARTED | 53 | 45 | 50 |
| COMPLETED | 40 | 40 | 32 |
| NOT COMPLETED | 13 | 5 | 18 |
Baseline Characteristics
| Arm/Group Title | Metal on Metal (MoM) | Controls | Ceramic on Ceramic (CoC) | Total |
|---|---|---|---|---|
| Arm/Group Description | All the patients of our Division with MoM THA | All the patients of our Division for primary THA | All the patients of our Division with CoC THA | Total of all reporting groups |
| Overall Participants | 40 | 40 | 32 | 112 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
50%
|
20
50%
|
20
62.5%
|
60
53.6%
|
| >=65 years |
20
50%
|
20
50%
|
12
37.5%
|
52
46.4%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
20
50%
|
25
62.5%
|
20
62.5%
|
65
58%
|
| Male |
20
50%
|
15
37.5%
|
12
37.5%
|
47
42%
|
Outcome Measures
| Title | Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l |
|---|---|
| Description | 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. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| the population was evaluated as number of patients with ions level above 7ug/l (attention limit) |
| Arm/Group Title | Metal on Metal (MoM) | Control |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 40 | 40 |
| Number [participants above limit] |
14
35%
|
0
0%
|
| Title | Duration of Articular Noise Produced During Level Walking |
|---|---|
| Description | 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) |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ceramic on Ceramic (CoC) | Metal on Metal (MoM) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 32 | 40 |
| Mean (Full Range) [milliseconds] |
174
|
40
|
| Title | Frequency of Articular Noise Produced During Level Walking |
|---|---|
| Description | 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) |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ceramic on Ceramic (CoC) | Metal on Metal (MoM) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 32 | 40 |
| Mean (Full Range) [Hz] |
910
|
100
|
| Title | Amplitude of Articular Noise Produced During Level Walking |
|---|---|
| Description | 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) |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ceramic on Ceramic (CoC) | Metal on Metal (MoM) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 32 | 40 |
| Mean (Full Range) [decibel] |
-20
|
-38
|
| Title | Number of Participants Who Scored Positive for ALVAL |
|---|---|
| Description | 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 |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| positive for ALVAL is +, negative for ALVAL is - |
| Arm/Group Title | Metal on Metal (MoM) |
|---|---|
| Arm/Group Description | |
| Measure Participants | 29 |
| Number [participants] |
15
37.5%
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Metal on Metal (MoM) | Ceramic on Ceramic (CoC) | Controls | |||
| Arm/Group Description | ||||||
All Cause Mortality |
||||||
| Metal on Metal (MoM) | Ceramic on Ceramic (CoC) | Controls | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Metal on Metal (MoM) | Ceramic on Ceramic (CoC) | Controls | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/40 (0%) | 0/32 (0%) | 0/40 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Metal on Metal (MoM) | Ceramic on Ceramic (CoC) | Controls | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/40 (0%) | 0/32 (0%) | 0/40 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Susanna Stea |
|---|---|
| Organization | Medical technology laboratory, Rizzoli Orthopaedic Institute |
| Phone | 00390516366861 |
| stea@tecno.ior.it |
- IORizzoli