Total Hip ReplacementLUUCNCT04903860
Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
A study testing total hip replacement with single use ancillary and total hip replacement with conventional ancillary in people with Total Hip Replacement and Coxarthrosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement, Coxarthrosis
- What is being tested?
- total hip replacement with single use ancillary and total hip replacement with conventional ancillary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- total hip replacement with single use ancillary, total hip replacement with conventional ancillary
- Keywords
- Prospective, Randomized study, Medico-economic, Sterilization, Single use reamer, Ancillary
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
total hip replacement with conventional ancillaryDevice
Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Single use reamers | Active comparator | Total hip replacement with the use of disposable reamers Receives: Device: total hip replacement with single use ancillary |
| conventional ancillary | Active comparator | Total hip replacement with the use of conventional reamers Receives: Device: total hip replacement with conventional ancillary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months
Secondary outcomes (10)
Surgical time
Calculated from the beginning of the skin incision to closure and recorded on the anesthesia sheet
Measured: intraoperative
Modified Merle d'Aubigné and Postel Method score
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.
Measured: Pré-opérative examination / At 3 months
Harris Hip Score
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.
Measured: Pré-opérative examination / At 3 months
Charnley classification and Devane score
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
Measured: Pré-opérative examination / At 3 months
WOMAC score
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).
Measured: Pré-opérative examination / At 3 months
HOOS score
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.
Measured: Pré-opérative examination / At 3 months
Pain evaluation
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).
Measured: Pré-opérative examination / At 3 months
Operator satisfaction
Operator satisfaction score (numerical scale from 0 (not satisfied) to 10 (very satisfied)) of the material during the surgical procedure
Measured: through surgical intervention an average of 1 day
Radiological analysis
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
Measured: At 3 months
Complications
Analysis of possible intraoperative and postoperative complications and their costs: loosening, infection, dislocation, wear and implant fracture
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start12 Jul 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Lépine
- Responsible party
- Sponsor
- Investigators
- Roger ERIVAN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903860
- Sponsor's protocol ID
- RBHP 2021 ERIVAN
- Other IDs
- 2021-A00363-38
- Acronym
- LUUC
- Status last verified
- Aug 2026
- First submitted
- 12 May 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37451339
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
- ClinicalTrials.gov ID
- NCT04903860
- Acronym / sponsor ID
- LUUC / RBHP 2021 ERIVAN
- Conditions
- Total Hip Replacement, Coxarthrosis
- Keywords
- Prospective, Randomized study, Medico-economic, Sterilization, Single use reamer, Ancillary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Groupe Lépine
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single use reamers | Active comparator | Device: total hip replacement with single use ancillaryTotal hip replacement with the use of disposable reamers |
| conventional ancillary | Active comparator | Device: total hip replacement with conventional ancillaryTotal hip replacement with the use of conventional reamers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip replacement with single use ancillaryComparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement | Device | Single use reamers |
| total hip replacement with conventional ancillaryComparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement | Device | conventional ancillary |
Primary outcome
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.
10 secondary outcomes
Surgical time
Time frame: intraoperative
Modified Merle d'Aubigné and Postel Method score
Time frame: Pré-opérative examination / At 3 months
Harris Hip Score
Time frame: Pré-opérative examination / At 3 months
Charnley classification and Devane score
Time frame: Pré-opérative examination / At 3 months
WOMAC score
Time frame: Pré-opérative examination / At 3 months
HOOS score
Time frame: Pré-opérative examination / At 3 months
Pain evaluation
Time frame: Pré-opérative examination / At 3 months
Operator satisfaction
Time frame: through surgical intervention an average of 1 day
Radiological analysis
Time frame: At 3 months
Complications
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 37451339Erivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger ERIVAN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip replacement with single use ancillary and total hip replacement with conventional ancillary in people with Total Hip Replacement and Coxarthrosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cost of surgery (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.