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

NCT ID: NCT04903860

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2022-07-27

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.

Conditions

Total Hip Replacement; Coxarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single use reamers

Total hip replacement with the use of disposable reamers

Group Type: ACTIVE_COMPARATOR

total hip replacement with single use ancillary

Intervention Type: DEVICE

Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

conventional ancillary

Total hip replacement with the use of conventional reamers

Group Type: ACTIVE_COMPARATOR

total hip replacement with conventional ancillary

Intervention Type: DEVICE

Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

Interventions

total hip replacement with single use ancillary

Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

Intervention Type: DEVICE

total hip replacement with conventional ancillary

Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Lépine

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger ERIVAN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU clermont-ferrand

Clermont-Ferrand, , France

Countries

France

References

Erivan R, Bourzat N, Mulliez A, Mougues C, Descamps S, Boisgard S, Villatte G. Single-use versus reusable ancillaries for dual mobility cup in total hip replacement. A prospective randomized short-term safety and feasibility comparison. Orthop Traumatol Surg Res. 2023 Nov;109(7):103658. doi: 10.1016/j.otsr.2023.103658. Epub 2023 Jul 13.

Reference Type: DERIVED

PMID: 37451339 (View on PubMed)

Other Identifiers

2021-A00363-38

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2021 ERIVAN

Identifier Type: -

Identifier Source: org_study_id