Avascular Necrosis, Degenerative Joint Disease
Conditions
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.
Interventions
DEVICETotal Hip Arthroplasty
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 1 year | Hip Flexion Angle at 1 year postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metal Ion | 3 month | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. |
| UCLA Activity Score | 5 year | 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 | 5 year | number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency) |
| Harris Hip Score | 5 year | 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. |
Countries
Japan
Participant flow
Recruitment details
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.
Pre-assignment details
Four patients withdrer before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 96 |
| 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). | 84 |
| Total | 180 |
Baseline characteristics
| Characteristic | M2a Taper | Total | M2a Magnum |
|---|---|---|---|
| Age, Continuous | 67 years | 66 years | 65 years |
| EQ-5D | 0.647 units on a scale | 0.633 units on a scale | 0.620 units on a scale |
| Harris Hip Score | 51.2 units on a scale | 51.7 units on a scale | 52.3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 84 Participants | 180 Participants | 96 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 84 participants | 180 participants | 96 participants |
| Sex: Female, Male Female | 61 Participants | 133 Participants | 72 Participants |
| Sex: Female, Male Male | 23 Participants | 47 Participants | 24 Participants |
| UCLA Activity Score | 3.0 units on a scale | 3.0 units on a scale | 3.1 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 3 / 84 |
| other Total, other adverse events | 2 / 96 | 3 / 84 |
| serious Total, serious adverse events | 1 / 96 | 1 / 84 |
Outcome results
Primary
Range of Motion
Hip Flexion Angle at 1 year postoperatively
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Range of Motion | 109.2 degrees |
| M2a Taper | Range of Motion | 110.2 degrees |
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.
Time frame: 5 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Harris Hip Score | 96.3 units on a scale |
| M2a Taper | Harris Hip Score | 94.5 units on a scale |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 5 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 1.07 microgram/Litter |
| M2a Taper | Metal Ion | 3.8 microgram/Litter |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 3 month
Population: 3 patients in M2a Taper group were failed to obtain Metal Ion data at 3 month follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 0.7 microgram/Litter |
| M2a Taper | Metal Ion | 0.9 microgram/Litter |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 3 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 0.98 microgram/Litter |
| M2a Taper | Metal Ion | 2.9 microgram/Litter |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 4 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 1.09 microgram/Litter |
| M2a Taper | Metal Ion | 3.1 microgram/Litter |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 6 month
Population: 4 patients in M2a Taper group were failed to obtain Metal Ion data at 6 month follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 0.9 microgram/Litter |
| M2a Taper | Metal Ion | 1.2 microgram/Litter |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 1.2 microgram/Litter |
| M2a Taper | Metal Ion | 1.8 microgram/Litter |
Secondary
Metal Ion
Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
Time frame: 2 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | Metal Ion | 1.2 microgram/Litter |
| M2a Taper | Metal Ion | 2.0 microgram/Litter |
Secondary
Radiographic Assessment
number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)
Time frame: 5 year
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M2a Magnum | Radiographic Assessment | Stem Osteolysis | 0 Participants |
| M2a Magnum | Radiographic Assessment | no abnormalities | 47 Participants |
| M2a Magnum | Radiographic Assessment | Stem Radiolucency | 2 Participants |
| M2a Magnum | Radiographic Assessment | Acetabular Radiolucency | 0 Participants |
| M2a Magnum | Radiographic Assessment | Heterotopic Ossification | 2 Participants |
| M2a Magnum | Radiographic Assessment | Acetabular Osteolysis | 0 Participants |
| M2a Taper | Radiographic Assessment | no abnormalities | 40 Participants |
| M2a Taper | Radiographic Assessment | Acetabular Osteolysis | 0 Participants |
| M2a Taper | Radiographic Assessment | Acetabular Radiolucency | 0 Participants |
| M2a Taper | Radiographic Assessment | Stem Osteolysis | 0 Participants |
| M2a Taper | Radiographic Assessment | Stem Radiolucency | 7 Participants |
| M2a Taper | Radiographic Assessment | Heterotopic Ossification | 1 Participants |
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.
Time frame: 5 year
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| M2a Magnum | UCLA Activity Score | 4.97 units on a scale |
| M2a Taper | UCLA Activity Score | 4.8 units on a scale |