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NCT04903860 | COMPLETED | Total Hip Replacement


Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Sponsor:

University Hospital, Clermont-Ferrand

Brief Summary:

The main objective of the study is to compare the use of single-use ancillary reaming material during total hip replacement and conventional reusable ancillary reaming material. The assessment will focus on the medico-economic differences found in this prospective randomized study

Condition or disease

Total Hip Replacement

Coxarthrosis

Intervention/treatment

total hip replacement with single use ancillary

total hip replacement with conventional ancillary

Phase

NA

Detailed Description:

In orthopaedics, the ancillary equipment is a generic term that includes all the instruments necessary for hip replacement surgery. The surgeon remains very dependent on these boxes of instruments, including rasps, reamers and trial implants (stems and trial heads), which are required in THR. Each instrument set is generally packaged in 2 or 3 boxes and each surgeon has a limited number of instrument sets at his disposal per operating day. Each ancillary device has a purchase cost, a maintenance cost (paid by the laboratories or distributors) and a sterilization cost, (paid by the health care institutions). Single-use reamers are instruments that are used on a single patient and then discarded. Performance and safety of use are optimized by providing a sterile and new product for each use. Therefore, it seems judicious to compare the medico-economic differences between the use of single-use reamers versus reusable reamers within a classic ancillary. This study will compare the costs incurred, the waste produced, the operating time, the satisfaction of the surgeon after the use of single-use reamers during total hip replacement, versus conventional re-sterilizable ancillary and verify the equivalence, three months after surgery, of clinical and radiological results.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Actual Study Start Date : 2021-07-12
Estimated Primary Completion Date : 2022-07-27
Estimated Study Completion Date : 2022-07-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * - Patient, male or female, over 18 years of age, eligible for a first-line total hip replacement for isolated coxarthrosis
  • * Patient registered to the national health system
  • * Patient able to understand information about the protocol and answer to questionnaire
Exclusion Criteria
  • * Pregnant, breastfeeding or potentially pregnant woman
  • * Major disability
  • * History of hip replacement surgery
  • * Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
  • * Morbid obesity as defined by body mass index (BMI) \>40 kg.m-2
  • * History of recent infection at the surgical site
  • * Surgical contraindication
  • * Refusal to participate

Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement

Location Details

NCT04903860


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Locations


Not yet recruiting

France,

CHU clermont-ferrand

Clermont-Ferrand, France,

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