NCT04903860

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

May 12, 2021

Last Update Submit

July 27, 2022

Conditions

Total Hip ReplacementCoxarthrosis

Keywords

ProspectiveRandomized studyMedico-economicSterilizationSingle use reamerAncillary

Outcome Measures

Primary Outcomes (1)

  • Overall cost of surgery

    Direct medical costing in both groups: * Sterilization costs, * Inventory management costs, * Material costs, * Waste management costs, * Operating room costs based on room occupancy times.

    At 3 months

Secondary Outcomes (10)

  • Surgical time

    intraoperative

  • Modified Merle d'Aubigné and Postel Method score

    Pré-opérative examination / At 3 months

  • Harris Hip Score

    Pré-opérative examination / At 3 months

  • Charnley classification and Devane score

    Pré-opérative examination / At 3 months

  • WOMAC score

    Pré-opérative examination / At 3 months

  • +5 more secondary outcomes

Study Arms (2)

Single use reamers

ACTIVE COMPARATOR

Total hip replacement with the use of disposable reamers

Device: total hip replacement with single use ancillary

conventional ancillary

ACTIVE COMPARATOR

Total hip replacement with the use of conventional reamers

Device: total hip replacement with conventional ancillary

Interventions

total hip replacement with single use ancillaryDEVICE

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

Single use reamers
total hip replacement with conventional ancillaryDEVICE

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

conventional ancillary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

Related Publications (1)

  • 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.

    PMID: 37451339DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Roger ERIVAN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 27, 2021

Study Start

July 12, 2021

Primary Completion

July 27, 2022

Study Completion

July 27, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

FR(1)