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Completed

NCT Number: NCT04903860

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total hip replacement with single use ancillary

Device

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

total hip replacement with conventional ancillary

Device

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

Primary outcomes

  1. Overall cost of surgery

    Time frame: At 3 months

    Direct medical costing in both groups:

    • Sterilization costs,
    • Inventory management costs,
    • Material costs,
    • Waste management costs,
    • Operating room costs based on room occupancy times.

Secondary outcomes

  1. Surgical time

    Time frame: intraoperative

    Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet

  2. Modified Merle d'Aubigné and Postel Method score

    Time frame: Pré-opérative examination / At 3 months

    The patients were evaluated by the Modified Merle d'Aubigné and Postel Method, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The total minimum score reached is 3, and the maximum is 18.

  3. Harris Hip Score

    Time frame: Pré-opérative examination / At 3 months

    This instrument has 10 items in 3 sections describing pain, function, range of motion, and deformity. The first section is questionnaire-based, answered by the patient, and includes impairments and activities. The second and third sections are administered by the therapist or physician, and include leg length measurement and range of motion (ROM) measures of the hip (flexion, abduction, external rotation and adduction). Each item has a unique numerical scale that corresponds to descriptive response options. The highest possible score is 100, with a higher score indicating less dysfunction.

  4. Charnley classification and Devane score

    Time frame: Pré-opérative examination / At 3 months

    Devane score: The purpose of this score is to specify the patient's activity level preoperatively. Initially established by Devane, it allows a classification of each patient in 5 categories from sedentary to athletic Charnley score: This is a commonly used score designed to assess the patient's overall disability in relation to gait function. It was published by Charnley and distinguishes patients into 3 categories

  5. WOMAC score

    Time frame: Pré-opérative examination / At 3 months

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of hip, including five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).

  6. HOOS score

    Time frame: Pré-opérative examination / At 3 months

    The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

  7. Pain evaluation

    Time frame: Pré-opérative examination / At 3 months

    The visual similar scale is auto completed. For the intensity of pain, the scale varies between "no pain" (the score of 0) and "most painful" (the score of 10).

  8. Operator satisfaction

    Time frame: through surgical intervention an average of 1 day

    Operator satisfaction score (numerical scale from 0 (not satisfied) to 10 (very satisfied)) of the material during the surgical procedure

  9. Radiological analysis

    Time frame: At 3 months

    realization of standard radiographs of the pelvis from the front, hip from the front and from the side. Analysis of the acetabulum according to Charnley and search for the presence of granulometry, migration or acetabular osteolysis. Measurement of the femoral and acetabular offset and height of the center of rotation

  10. Complications

    Time frame: At 3 months

    Analysis of possible intraoperative and postoperative complications and their costs: loosening, infection, dislocation, wear and implant fracture

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Groupe Lépine

Registry information

Acronym: LUUC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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