Multiple Electrode Aggregometry to Assess Platelet Function in Patients Undergoing Hip Joint Alloplasty With and Without Bone Cement (APJAB)

Medical University of Warsaw

Status: Completed

Conditions: Methylmethacrylate Embolism; Arthroplasty; Platelet Aggregation

Treatments: Other: Blood sample 2; Other: Blood sample 1

Study type: Observational

Funder types: Other

Identifiers

NCT03121378

APJAB

Details and patient eligibility

About

The aim of the study is to assess blood platelet function and activation in patients undergoing both cement and non cement hip joint total alloplasty. Bone cement is used as a special biomaterial to help fix a hip prosthesis in place but is associated with bone cement implantation syndrome causing such complications as hypotension, cardiac arrhythmias. The pathophysiology of bone cement implantation syndrome is not fully known but one theory supports formation of clots in the bloodstream. This directly would activate platelets but no such study has been performed in humans. As bone reaming could potentially cause platelet activation even without bone cement, the study involves a control group of patients undergoing non cemented joint alloplasty.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients qualified for hip arthroplasty
• Signed consent for study
• No abnormality in coagulation screen
• Not taking regular antiplatelet medication except small dose of acetylsalicylic acid

Exclusion criteria

• Lack of consent
• Low platelet count (<100 thousand) in standard preoperative full blood count
• On regular antiplatelet medication (except 75mg acetylsalicylic acid)

Trial design

36 participants in 2 patient groups

Hip arthroplasty with bone cement

Description:

Patients undergoing hip replacement surgery with bone cement use: blood samples taken before cement use and after cement prosthesis fixation.

Treatment:

Other: Blood sample 2

Other: Blood sample 1

Non cement hip arthroplasty

Description:

Patients undergoing hip replacement surgery without bone cement. Blood samples taken before bone reaming and after implantation of femoral prosthesis.

Treatment:

Other: Blood sample 2

Other: Blood sample 1