Degenerative Joint DiseaseNCT01010763
A Study on M2a Magnum Total Hip Arthroplasty
A study testing Total Hip Arthroplasty in people with Degenerative Joint Disease and Avascular Necrosis, run by Zimmer Biomet at 1 site in Japan.
Trial summary
The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Degenerative Joint Disease, Avascular Necrosis
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2009to 28 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suitable for primary Total Hip Replacement
- Patients aged over 20
- Patients with limited co-morbidity- ASA I-III
- Patients must be able to understand instructions and be willing to return for follow-up
- Patients willing to provide blood and urine samples for metal ion analysis at follow-up
Who cannot join
- Pre-existing metal implants
- Infection, sepsis, and osteomyelitis
- Uncooperative patient or pt with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- osteomalacia
Show all 10Show fewer
- distant foci of infections which may spread to the implant site
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- vascular insufficiency, muscular atrophy, or neuromuscular disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.
Read the detailed description
There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.
- Conditions
- Degenerative Joint Disease, Avascular Necrosis
- Being tested
- Total Hip Arthroplasty
- Medical subject headings
- Joint Diseases, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
| Study group | Role | What they receive |
|---|---|---|
| M2a Magnum | Experimental | Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm. Receives: Device: Total Hip Arthroplasty |
| M2a Taper | Active comparator | Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head. Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Hip Flexion Angle at 1 year postoperatively
Measured: 1 year
Secondary outcomes (10)
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 3 month
UCLA Activity Score
UCLA is physician assessing scoring system to assess patient's activity level. Minimum score is 0 (completely inactive) and maximum score is 9 (Regularly participates in impact sports) with 1 point increments depending on patient's activity level.
Higher score means higher activity level achieved.
Measured: 5 year
Radiographic Assessment
number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)
Measured: 5 year
Harris Hip Score
Harris Hip Score is physician assessing hip functional scoring system, which includes 4 components (pain, function, deformity and range of motion) with minimum score of 0 \& maximum score of 100.
Maximum \& Minimum score of each subscale is pain: 0-44, function: 0-47, Deformity: 0-4 and Range of motion: 0-5.
Current report uses summed score of each patient to compare total Harris Hip Score.
Higher score means better outcomes.
Measured: 5 year
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 6 month
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 1 year
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 2 year
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 3 year
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 4 year
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completion28 Feb 2017
- Study completion28 Apr 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Joint DiseaseStudies 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
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenji Ozono, M.D., Ph.D., Principal investigator, Kansai Rosai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010763
- Sponsor's protocol ID
- INT.CR.RROW2
- Status last verified
- Mar 2019
- First submitted
- 5 Nov 2009
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ando W, Yamamoto K, Atsumi T, Tamaoki S, Oinuma K, Shiratsuchi H, Tokunaga H, Inaba Y, Kobayashi N, Aihara M, Ohzono K. Comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study. J Orthop. 2015 Jun 10;12(4):228-36. doi: 10.1016/j.jor.2015.05.008. eCollection 2015 Dec.
PubMed 26566324
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01010763
- Acronym / sponsor ID
- INT.CR.RROW2
- Conditions
- Degenerative Joint Disease, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2009 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.
Detailed description
There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M2a Magnum | Experimental | Device: Total Hip ArthroplastyTotal HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm. |
| M2a Taper | Active comparator | Device: Total Hip ArthroplastyTotal Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suitable for primary Total Hip Replacement
- Patients aged over 20
- Patients with limited co-morbidity- ASA I-III
- Patients must be able to understand instructions and be willing to return for follow-up
- Patients willing to provide blood and urine samples for metal ion analysis at follow-up
Key exclusion criteria (10 listed)
- Pre-existing metal implants
- Infection, sepsis, and osteomyelitis
- Uncooperative patient or pt 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 |
|---|---|---|
| Total Hip ArthroplastyDegenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). | Device | M2a Magnum, M2a Taper |
Primary outcome
Range of Motion
Time frame: 1 year
Hip Flexion Angle at 1 year postoperatively
10 secondary outcomes
Metal Ion
Time frame: 3 month
UCLA Activity Score
Time frame: 5 year
Radiographic Assessment
Time frame: 5 year
Harris Hip Score
Time frame: 5 year
Metal Ion
Time frame: 6 month
Metal Ion
Time frame: 1 year
Metal Ion
Time frame: 2 year
Metal Ion
Time frame: 3 year
Metal Ion
Time frame: 4 year
Metal Ion
Time frame: 5 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26566324Ando W, Yamamoto K, Atsumi T, Tamaoki S, Oinuma K, Shiratsuchi H, Tokunaga H, Inaba Y, Kobayashi N, Aihara M, Ohzono K. Comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study. J Orthop. 2015 Jun 10;12(4):228-36. doi: 10.1016/j.jor.2015.05.008. eCollection 2015 Dec.
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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.
Kenji Ozono, M.D., Ph.D. principal investigator
Kansai Rosai Hospital
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 Arthroplasty in people with Degenerative Joint Disease and Avascular Necrosis, run by Zimmer Biomet at 1 site 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 5 inclusion and 10 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 21 Jun 2019. 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 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 21 Jun 2019). 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?
Range of Motion (time frame: 1 year). 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 NCT01010763, 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 21 Jun 2019.