Metal on Metal Hip Implant Registry

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From this document you will learn the answers to the following questions:

  • What information is on the left?

  • Does pt have clinically significant what?

  • What is the main component of the hip prosthesis?

Transcription

1 Data Collection Metal on Metal Hip Implant Registry questions related to data entry to Principal Investigator Jeffrey Brent, M.D., Ph.D. Prosthesis Information Enter prosthesis information Prosthesis on left? Metal-on-metal? Large femoral head > 31 mm Was this a DePuy ASR implant? If not metal-on-metal, please specify Metal-on-ceramic Ceramic-on-ceramic Metal-onpolyethylene Other: Years since implantation of current implant Is this the first prosthesis on the left? Years since implantation of first left hip prosthesis If no Years since implantation of first implant Was prior prosthesis on left metal-on-metal? If no If not metal-on-metal, please specify Metal-on-ceramic Ceramic-on-ceramic Metal-onpolyethylene Other: Prosthesis on right? Metal-on-metal? Large femoral head > 31 mm

2 Was this a DePuy ASR implant? Years since implantation of current implant Is this the first hip prosthesis on the right? Years since implantation of first right hip prosthesis Medical Status Enter medical status information Does pt currently have hypothyroidism (by prior diagnosis or TSH>ULN)? Does pt have polycythemia (Hct > 50%) Has pt had clinically significant sludging? Is pt obese (BMI >30)? Does pt have sleep apnea? Was polycythemia present before current prosthesis or prostheses? Was polycythemia present before first prosthesis?

3 Does the pt have a rash? Does pt have an egfr < 60 mls/min? Does pt have a known malignancy? Specify type of malignancy Does pt have a neurologist diagnosed peripheral demyelinating neuropathy? Does pt have a neurologist diagnosed peripheral axonal neuropathy?

4 Does pt have an ophthalmologist or neurologist diagnosed optic neuropathy? Does pt have subjective hearing loss? Does pt have tinnitus? Does pt have echocardiographically diagnosed diastolic dysfunction?

5 Does pt have echocardiographically diagnosed ejection fraction < 40%? Ion Concentrations Enter Ion concentration information Most recent whole blood Cobalt concentration: ug/l Most recent serum cobalt concentration: ug/l Most recent plasma cobalt concentration: ug/l Since current or last implantation: Peak whole blood cobalt concentration: ug/l Peak serum cobalt concentration: ug/l Peak plasma cobalt concentration: ug/l Was current or last implantation a revision? If yes Peak whole blood cobalt concentration prior to current implant or revision: ug/l If yes Peak serum cobalt concentration prior to current implant or revision: ug/l If yes Peak plasma cobalt concentration prior to current implant or revision: ug/l Most recent whole blood chromium concentration: ug/l Most recent serum chromium concentration: ug/l Most recent plasma chromium concentration: ug/l

6 Since current or last implantation: Peak whole blood chromium concentration: ug/l Peak serum chromium concentration: ug/l Peak plasma chromium concentration: ug/l Was current or last implantation a revision? If yes Peak whole blood chromium concentration prior to current implant or revision: ug/l If yes Peak serum chromium concentration prior to current implant or revision: ug/l If yes Peak plasma chromium concentration prior to current implant or revision: ug/l Imaging Enter imaging information Ultrasound Pseudotumor present since last implantation on either side MARS-MRI Pseudotumor present since last implantation on either side Surgical Site Integrity Enter surgical site integrity information Right Well healed Draining Erythematous Gapping implant on right Left Well healed Draining Erythematous Gapping implant on left Hypersensitivity Testing Enter hypersensitivity testing information Was any hypersensitivity testing done?

7 For cobalt Metal on Metal Hip Implant Registry Type of testing Positive Negative Equivocal When was the testing done? Before implantation of metal implant While metal implant was in After removal of metal implant For chromium Type of testing Positive Negative Equivocal When was the testing done? Before implantation of metal implant While metal implant was in After removal of metal implant Please specify the name(s) of the treating toxicologist(s)

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