Clinical trial NCT04903860: Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Official title: Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Coxarthrosis
Keywords: Prospective
Randomized study
Medico-economic
Sterilization
Single use reamer
Ancillary
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Groupe Lépine
First posted: 2021-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Overall cost of surgery
timeFrame: At 3 months
Secondary outcomes:
measure: Surgical time
timeFrame: intraoperative
measure: Modified Merle d'Aubigné and Postel Method score
timeFrame: Pré-opérative examination / At 3 months
measure: Harris Hip Score
timeFrame: Pré-opérative examination / At 3 months
measure: Charnley classification and Devane score
timeFrame: Pré-opérative examination / At 3 months
measure: WOMAC score
timeFrame: Pré-opérative examination / At 3 months
measure: HOOS score
timeFrame: Pré-opérative examination / At 3 months
measure: Pain evaluation
timeFrame: Pré-opérative examination / At 3 months
measure: Operator satisfaction
timeFrame: through surgical intervention an average of 1 day
measure: Radiological analysis
timeFrame: At 3 months
measure: Complications
timeFrame: At 3 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Roger ERIVAN
role: PRINCIPAL_INVESTIGATOR
References: