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The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Device | Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion | Hip Flexion Angle at 1 year postoperatively | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenji Ozono, M.D., Ph.D. | Kansai Rosai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Rosai Hospital | Amagasaki | Hyogo Pref. | 660-8511 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26566324 | Derived | 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. |
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Four patients withdrer before randomization.
Period of Recruitment was from December 2009 until December 2011. Recruitements were done at medical clinics by providing detailed explanation of procedure as well as study protocol, including randomization & right of withdrawal.
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| ID | Title | Description |
|---|---|---|
| FG000 | M2a Magnum | 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. Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). |
| FG001 | M2a Taper | 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. Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | M2a Magnum | 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. Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Range of Motion | Hip Flexion Angle at 1 year postoperatively | 2 patients in M2a Magnum group and 4 patients in M2a Taper group were failed to obtain Range of Motion data at 1 year follow-up visit. | Posted | Mean | Full Range | degrees | 1 year |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M2a Magnum | 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. Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision due to Adverse Reaction to Metal Debris | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Affairs | Zimmer Biomet G.K. | +81-3-6402-6610 | takahito.nakai@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2015 | Mar 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 5 year |
| Radiographic Assessment | number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency) | 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. | 5 year |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 6 month |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 1 year |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 2 year |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 3 year |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 4 year |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 5 year |
| BG001 | M2a Taper | 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. Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Preoperative Harris Hip Score of two patients in Magnum arm were failed to obtain. | Mean | Full Range | units on a scale |
|
| EQ-5D | EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000. Higher score means better outcomes. | Preoperative EQ-5D questionnaire was not completed by two subjects (one subject each arm). | Mean | Full Range | units on a scale |
|
| 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. | Mean | Full Range | units on a scale |
|
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.
Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 3 patients in M2a Taper group were failed to obtain Metal Ion data at 3 month follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 3 month |
|
|
|
| Secondary | 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. | 59 patients in M2a Magnum group and 59 patients in M2a Taper group were failed to obtain UCLA Activity Score data at 5 year follow-up visit. | Posted | Mean | Full Range | units on a scale | 5 year |
|
|
|
| Secondary | Radiographic Assessment | number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency) | 45 patients in M2a Magnum group and 36 patients in M2a Taper group were failed to be assessed radiographically at 5 year follow-up visit. | Posted | Count of Participants | Participants | 5 year |
|
|
|
| Secondary | 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. | 68 patients in M2a Magnum group and 62 patients in M2a Taper group were failed to obtain Harris Hip Score data at 5 year follow-up visit. | Posted | Mean | Full Range | units on a scale | 5 year |
|
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 4 patients in M2a Taper group were failed to obtain Metal Ion data at 6 month follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 6 month |
|
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 7 patients in M2a Magnum group and 9 patients in M2a Taper group were failed to obtain Metal Ion data at 1 year follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 1 year |
|
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 12 patients in M2a Magnum group and 10 patients in M2a Taper group were failed to obtain Metal Ion data at 2 year follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 2 year |
|
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 21 patients in M2a Magnum group and 19 patients in M2a Taper group were failed to obtain Metal Ion data at 3 year follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 3 year |
|
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 50 patients in M2a Magnum group and 46 patients in M2a Taper group were failed to obtain Metal Ion data at 4 year follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 4 year |
|
|
|
| Secondary | Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 33 patients in M2a Magnum group and 30 patients in M2a Taper group were failed to obtain Metal Ion data at 5 year follow-up visit. | Posted | Mean | Full Range | microgram/Litter | 5 year |
|
|
|
| 0 |
| 96 |
| 1 |
| 96 |
| 2 |
| 96 |
| EG001 | M2a Taper | 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. Total Hip Arthroplasty: Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only). | 3 | 84 | 1 | 84 | 3 | 84 |
| Femoral Epicondyle Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cerebral Infarction | Vascular disorders | Non-systematic Assessment |
|
| Intra-operative fracture | Surgical and medical procedures | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stem Osteolysis |
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| Stem Radiolucency |
|
| Heterotopic Ossification |
|
| no abnormalities |
|