Osteoarthritis, HipNCT01952067
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis
A study testing line-to-line reaming and cementing technique and standard over-reaming with 2 broach sizes in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- line-to-line reaming and cementing technique and standard over-reaming with 2 broach sizes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to 20 Jun 2017
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring cemented primary total hip replacement.
- Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery
Who cannot join
- Patients who require revision of a previously implanted total hip replacement (THR)
- Patients who will receive a THR without cement
- Patients who have had a prior procedure of osteotomy on the femur
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI >35)
- Patients with active or suspected infection
- Patients with malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial
The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.
Furthermore pain, postoperative outcome and patient satisfaction will be assessed.
- Conditions
- Osteoarthritis, Hip
- Being tested
- line-to-line reaming and cementing technique, standard over-reaming with 2 broach sizes
- Keywords
- Hip Prosthesis, surgery, cements, Radiostereometric Analysis
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
line-to-line reaming and cementing techniqueProcedure or surgery
standard over-reaming with 2 broach sizesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| line-to-line reaming | Experimental | Corail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup Receives: Procedure: line-to-line reaming and cementing technique |
| standard over-reaming | Active comparator | Corail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup Receives: Procedure: standard over-reaming with 2 broach sizes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in subsidence of femoral stems of 200 microns
Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem
Measured: change from 6th day postoperative to 24 months
Secondary outcomes (5)
Oxford Hip Score
12 questions. Every question is scored 4 to 0 according to the selected response.
Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0).
Measured: change from 6th day postoperative to 24 months
EQ-5D-5L
5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office. 5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office.
Measured: change from 6th day postoperative to 24 months
Harris Hip Score (HHS)
Four subscales make up HHS. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points).
The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: change from 6th day postoperative to 24 months
Visual Assessment Scale (VAS) for pain
A horizontal or vertical 10 cm line labelled at each end by descriptors such as 'no pain' and 'worse pain ever'. The patient marks the line to indicate pain severity and it is simply quantified by measuring the distance in cm from 0 (no pain) to the patient's marked rating.
Measured: change from 6th day postoperative to 24 months
Merle D'Aubigne scale
The score includes the parameters pain, mobility, and ability to walk, with each rated from 0 points (worst condition) to 6 points (best condition). Addition of the scores for pain and mobility results in an absolute estimation of hip function.
Measured: change from 6th day postoperative to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startMar 2013
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
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 Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Kristiansund Hospital, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Otto Schnell Husby, md phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952067
- Sponsor's protocol ID
- 4.2008.1996
- Status last verified
- Apr 2022
- First submitted
- 5 Sep 2013
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sevaldsen K, Schnell Husby O, Lian OB, Farran KM, Schnell Husby V. Is the French Paradox cementing philosophy superior to the standard cementing? A randomized controlled radiostereometric trial and comparative analysis. Bone Joint J. 2022 Jan;104-B(1):19-26. doi: 10.1302/0301-620X.104B1.BJJ-2021-0325.R2.
PubMed 34969272
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial
- ClinicalTrials.gov ID
- NCT01952067
- Acronym / sponsor ID
- 4.2008.1996
- Conditions
- Osteoarthritis, Hip
- Keywords
- Hip Prosthesis, surgery, cements, Radiostereometric Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Kristiansund Hospital, St. Olavs Hospital
- Study start
- Mar 2013 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 27 Sep 2013 (estimated)
- 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 primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.
Furthermore pain, postoperative outcome and patient satisfaction will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| line-to-line reaming | Experimental | Procedure: line-to-line reaming and cementing techniqueCorail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup |
| standard over-reaming | Active comparator | Procedure: standard over-reaming with 2 broach sizesCorail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients requiring cemented primary total hip replacement.
- Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery
Key exclusion criteria (6 listed)
- Patients who require revision of a previously implanted total hip replacement (THR)
- Patients who will receive a THR without cement
- Patients who have had a prior procedure of osteotomy on the femur
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI >35)
- Patients with active or suspected infection
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 |
|---|---|---|
| line-to-line reaming and cementing technique | Procedure or surgery | line-to-line reaming |
| standard over-reaming with 2 broach sizes | Procedure or surgery | standard over-reaming |
Primary outcome
Difference in subsidence of femoral stems of 200 microns
Time frame: change from 6th day postoperative to 24 months
Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem
5 secondary outcomes
Oxford Hip Score
Time frame: change from 6th day postoperative to 24 months
EQ-5D-5L
Time frame: change from 6th day postoperative to 24 months
Harris Hip Score (HHS)
Time frame: change from 6th day postoperative to 24 months
Visual Assessment Scale (VAS) for pain
Time frame: change from 6th day postoperative to 24 months
Merle D'Aubigne scale
Time frame: change from 6th day postoperative to 24 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 4 May 2022.
- Results publication: PubMed 34969272Sevaldsen K, Schnell Husby O, Lian OB, Farran KM, Schnell Husby V. Is the French Paradox cementing philosophy superior to the standard cementing? A randomized controlled radiostereometric trial and comparative analysis. Bone Joint J. 2022 Jan;104-B(1):19-26. doi: 10.1302/0301-620X.104B1.BJJ-2021-0325.R2.
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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.
Otto Schnell Husby, md phd study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing line-to-line reaming and cementing technique and standard over-reaming with 2 broach sizes in people with Osteoarthritis, Hip, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 inclusion and 6 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 4 May 2022. 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 Norway. 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?
Difference in subsidence of femoral stems of 200 microns (time frame: change from 6th day postoperative to 24 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 NCT01952067, 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 4 May 2022.