Clinical trial NCT02208271: A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Official title: A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Arthritis, Failure of Total Hip
Keywords: tissue necrosis
metal on metal total hip
biomarker
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Charlotte Orthopedic Hospital
First posted: 2014-08-05
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of a total of 100 hip patients will be enrolled at orthopedic clinics.

Brief summary: The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement.

A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.

Detailed description: Well-functioning MoM implants have shown an increase in serum cobalt and chromium (CoCr) ion levels from the metal debris generated from the implant wear.However, the current evidence suggests that measuring ion levels is unreliable and that increasing ion levels do not correlate with tissue damage. In addition to measuring blood and synovial fluid metal ion levels, ultrasound and MRI with metal artifact reduction sequences (MARS) have been utilized to assess periarticular reactions secondary to metal wear debris. Despite metal reduction software these scans are frequently difficult to interpret. While each of these tests has merit, at the present time there is no single diagnostic test available which delineates the key issue that demands urgent surgical intervention, i.e. tissue necrosis. It is important to have a reliable test to guide surgeons and patients in the shared decision-making process of when surgical intervention is necessary to prevent disabling tissue damage. For this reason, the current study proposes an examination of preoperative serum samples of subjects in addition to synovial fluid collected during revision surgery for biomarkers that may indicate tissue necrosis. To maximize the chance of success of identifying serum biomarkers, all samples will be analyzed using multianalyte assay, biomarker tests. The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement.

A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested within 6 months of the date of the planned revision surgery.
* Patients presenting for a metal on poly hip revision
* Revision hip patients must be greater than one year postoperative
* The diagnosis at the time of the index, or primary, hip replacement was osteoarthritis.
* Patients who have hip osteoarthritis but have not had a total hip surgery (control)

Exclusion Criteria:

* Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested \>6 months of the date of the planned revision
* Patients with a total hip on the contralateral side.
* Patients with a prior history of periprosthetic infection
* Revision cases where the diagnosis at the time of the index, or primary, hip replacement was not osteoarthritis.
* Prisoners
* Patients not willing to consent for the proposed treatment
* Patients with an altered mental status
* Active, concurrent metastatic infection
* Active, superficial infection
* Patients presenting for a metal on poly hip revision to treat trunionosis

Primary outcomes:
measure: The number of patients with serum and synovial fluid biomarkers
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: The number of patients with tissue necrosis
timeFrame: participants will be followed for the duration of their hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Thomas Fehring, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Campbell P, Ebramzadeh E, Nelson S, Takamura K, De Smet K, Amstutz HC. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res. 2010 Sep;468(9):2321-7. doi: 10.1007/s11999-010-1372-y.
citation: Leopold SS, Berger RA, Patterson L, Skipor AK, Urban RM, Jacobs JJ. Serum titanium level for diagnosis of a failed, metal-backed patellar component. J Arthroplasty. 2000 Oct;15(7):938-43. doi: 10.1054/arth.2000.6632.
citation: Griffin WL, Fehring TK, Kudrna JC, Schmidt RH, Christie MJ, Odum SM, Dennos AC. Are metal ion levels a useful trigger for surgical intervention? J Arthroplasty. 2012 Sep;27(8 Suppl):32-6. doi: 10.1016/j.arth.2012.03.020. Epub 2012 May 17.