Hip OsteoarthritisNCT01883492
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
A study testing Femoral Stem, Acetabular Cup and Acetabular Liner in people with Hip Osteoarthritis, run by Zimmer Biomet at 5 sites in Japan.
Trial summary
The primary objectives of this clinical study include: Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1 Compare E1 wear used with CoCr and Biolox Delta heads Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Femoral Stem, Acetabular Cup and Acetabular Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 5 sitesJapan
- Study dates
- 11 Mar 2013to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis
- Age between 20 - 75 at the time of operation
- Patients with limited co-morbidity -ASA I-III
- Patients must be able to understand instructions and be willing to return for follow up
Who cannot join
- In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.
- Absolute contraindications include: infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
Show all 11Show fewer
- osteomalacia,
- distant foci of infections which may spread to the implant site,
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
- vascular insufficiency, muscular atrophy, or neuromuscular disease.
- pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Fukuoka University School of Medicine
Fukuoka, Fukuoka, 814-0180
Saiseikai Nakatsu Hospital
Osaka, 530-0012
Kitasato University School of Medicine
Sagamihara, Kanagawa, 252-0374
Kitasato University Kitasato Institute Hospital
Tokyo, 108-8642
Keio University School of Medicine
Tokyo, 160-8582
About this study
Official title: A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
The primary objectives of this clinical study include:
- Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
- Compare E1 wear used with CoCr and Biolox Delta heads
Read the detailed description
This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.
Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.
Randomization will occur via random number generator by 4 blocks randomization.
- Conditions
- Hip Osteoarthritis
- Being tested
- Femoral Stem, Acetabular Cup, Acetabular Liner
- Keywords
- Only Female, Age between 20 - 75 at the time of operation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral StemDevice
Also called Taperloc Complete, Taperloc Microplasty Complete, Taperloc Complete XR123, Taperloc Microplasty Complete XR123
JMDN classification/Class III device
Acetabular CupDevice
Also called Ringloc Acetabular Cup, Regenerex Ringloc+ Acetabular Cup
JMDN classification: Class III device
Acetabular LinerDevice
Also called E1 Ringloc Liner
JMDN classification: Class III device
| Study group | Role | What they receive |
|---|---|---|
| BIOLOX delta head | Experimental | Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1. Receives: Device: Femoral Stem; Device: Acetabular Cup; Device: Acetabular Liner |
| CoCr head | Active comparator | Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1. Receives: Device: Femoral Stem; Device: Acetabular Cup; Device: Acetabular Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
Measured: Immediate postoperative and 2 year postoperatively
Secondary outcomes (12)
Harris Hip Score at 6 Month Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".
Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Measured: 6 month postoperative
Harris Hip Score at 1 Year Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".
Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Measured: 1 year postoperative
Harris Hip Score at 2 Year Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".
Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Measured: 2 year postoperative
Harris Hip Score at 3 Year Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".
Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Measured: 3 year postoperative
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.
The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 6 month postoperative
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.
The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 1 year postoperative
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.
The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 2 year postoperative
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.
The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 3 year postoperative
UCLA Activity Score at 6 Month Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.
The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Measured: 6 month postoperative
UCLA Activity Score at 1 Year Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.
The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Measured: 1 year postoperative
UCLA Activity Score at 2 Year Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.
The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Measured: 2 year postoperative
UCLA Activity Score at 3 Year Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.
The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Measured: 3 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study start11 Mar 2013
- Primary completion6 Feb 2019
- Study completion15 Mar 2019
Why it stopped: Enrollment of the subject could not reach statistically required number.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hirotsugu Ohashi, M.D., Ph.D., Principal investigator, Saiseikai Nakatsu HospitalArihiko Kanaji, M.D., Ph.D., Principal investigator, Keio UniversityKatsufumi Uchiyama, M.D., Ph.D., Principal investigator, Kitasato University School of MedicineHironori Kaneko, M.D., Ph.D., Principal investigator, Kitasato University Kitasato Institute HospitalKoichi Kinoshita, M.D., Ph.D., Principal investigator, Fukuoka University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883492
- Sponsor's protocol ID
- INT.CR.GH2
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2013
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
- ClinicalTrials.gov ID
- NCT01883492
- Acronym / sponsor ID
- INT.CR.GH2
- Conditions
- Hip Osteoarthritis
- Keywords
- Only Female, Age between 20 - 75 at the time of operation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment of the subject could not reach statistically required number.
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this clinical study include:
- Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
- Compare E1 wear used with CoCr and Biolox Delta heads
Detailed description
This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.
Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.
Randomization will occur via random number generator by 4 blocks randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIOLOX delta head | Experimental | Device: Femoral Stem, Device: Acetabular Cup, Device: Acetabular LinerUncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s). Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup. Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1. |
| CoCr head | Active comparator | Device: Femoral Stem, Device: Acetabular Cup, Device: Acetabular LinerUncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s). Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup. CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthritis
- Age between 20 - 75 at the time of operation
- Patients with limited co-morbidity -ASA I-III
- Patients must be able to understand instructions and be willing to return for follow up
Key exclusion criteria (11 listed)
- In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.
- Absolute contraindications include: infection, sepsis, and osteomyelitis.
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
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 |
|---|---|---|
| Femoral StemAlso: Taperloc Complete, Taperloc Microplasty Complete, Taperloc Complete XR123, Taperloc Microplasty Complete XR123JMDN classification/Class III device | Device | BIOLOX delta head, CoCr head |
| Acetabular CupAlso: Ringloc Acetabular Cup, Regenerex Ringloc+ Acetabular CupJMDN classification: Class III device | Device | BIOLOX delta head, CoCr head |
| Acetabular LinerAlso: E1 Ringloc LinerJMDN classification: Class III device | Device | BIOLOX delta head, CoCr head |
Primary outcome
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
Time frame: Immediate postoperative and 2 year postoperatively
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
12 secondary outcomes
Harris Hip Score at 6 Month Follow-up Visit
Time frame: 6 month postoperative
Harris Hip Score at 1 Year Follow-up Visit
Time frame: 1 year postoperative
Harris Hip Score at 2 Year Follow-up Visit
Time frame: 2 year postoperative
Harris Hip Score at 3 Year Follow-up Visit
Time frame: 3 year postoperative
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
Time frame: 6 month postoperative
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
Time frame: 1 year postoperative
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
Time frame: 2 year postoperative
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
Time frame: 3 year postoperative
UCLA Activity Score at 6 Month Follow-up Visit
Time frame: 6 month postoperative
UCLA Activity Score at 1 Year Follow-up Visit
Time frame: 1 year postoperative
UCLA Activity Score at 2 Year Follow-up Visit
Time frame: 2 year postoperative
UCLA Activity Score at 3 Year Follow-up Visit
Time frame: 3 year postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hirotsugu Ohashi, M.D., Ph.D. principal investigator
Saiseikai Nakatsu Hospital
Arihiko Kanaji, M.D., Ph.D. principal investigator
Keio University
Katsufumi Uchiyama, M.D., Ph.D. principal investigator
Kitasato University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Stem, Acetabular Cup and Acetabular Liner in people with Hip Osteoarthritis, run by Zimmer Biomet at 5 sites in Japan.
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 11 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: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period (time frame: Immediate postoperative and 2 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2020.