Back to resultsA Study on M2a Magnum Total Hip Arthroplasty
Primary Purpose
Degenerative Joint Disease, Avascular Necrosis
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Joint Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Kansai Rosai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
M2a Magnum
M2a Taper
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Range of Motion
Hip Flexion Angle at 1 year postoperatively
Secondary Outcome Measures
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
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.
Radiographic Assessment
number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)
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.
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01010763
Brief Title
A Study on M2a Magnum Total Hip Arthroplasty
Official Title
A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
April 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease, Avascular Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M2a Magnum
Arm Type
Experimental
Arm Description
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.
Arm Title
M2a Taper
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
Primary Outcome Measure Information:
Title
Range of Motion
Description
Hip Flexion Angle at 1 year postoperatively
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
3 month
Title
UCLA Activity Score
Description
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.
Time Frame
5 year
Title
Radiographic Assessment
Description
number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)
Time Frame
5 year
Title
Harris Hip Score
Description
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.
Time Frame
5 year
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
6 month
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
1 year
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
2 year
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
3 year
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
4 year
Title
Metal Ion
Description
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time Frame
5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenji Ozono, M.D., Ph.D.
Organizational Affiliation
Kansai Rosai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo Pref.
ZIP/Postal Code
660-8511
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26566324
Citation
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.
Results Reference
derived
Learn more about this trial
A Study on M2a Magnum Total Hip Arthroplasty
We'll reach out to this number within 24 hrs