Trial Outcomes & Findings for A Study on M2a Magnum Total Hip Arthroplasty (NCT NCT01010763)

NCT ID: NCT01010763

Last Updated: 2019-06-21

Results Overview

Hip Flexion Angle at 1 year postoperatively

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 184 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-06-21

Participant Flow

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.

Four patients withdrer before randomization.

Participant milestones

Measure	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).	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).
Overall Study STARTED	96	84
Overall Study COMPLETED	61	54
Overall Study NOT COMPLETED	35	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Harris Hip Score of two patients in Magnum arm were failed to obtain.

Baseline characteristics by cohort

Measure	M2a Magnum n=96 Participants 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).	M2a Taper n=84 Participants 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).	Total n=180 Participants Total of all reporting groups
Age, Continuous	65 years n=96 Participants	67 years n=84 Participants	66 years n=180 Participants
Sex: Female, Male Female	72 Participants n=96 Participants	61 Participants n=84 Participants	133 Participants n=180 Participants
Sex: Female, Male Male	24 Participants n=96 Participants	23 Participants n=84 Participants	47 Participants n=180 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=96 Participants	0 Participants n=84 Participants	0 Participants n=180 Participants
Race (NIH/OMB) Asian	96 Participants n=96 Participants	84 Participants n=84 Participants	180 Participants n=180 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=96 Participants	0 Participants n=84 Participants	0 Participants n=180 Participants
Race (NIH/OMB) Black or African American	0 Participants n=96 Participants	0 Participants n=84 Participants	0 Participants n=180 Participants
Race (NIH/OMB) White	0 Participants n=96 Participants	0 Participants n=84 Participants	0 Participants n=180 Participants
Race (NIH/OMB) More than one race	0 Participants n=96 Participants	0 Participants n=84 Participants	0 Participants n=180 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=96 Participants	0 Participants n=84 Participants	0 Participants n=180 Participants
Region of Enrollment Japan	96 participants n=96 Participants	84 participants n=84 Participants	180 participants n=180 Participants
Harris Hip Score	52.3 units on a scale n=94 Participants • Preoperative Harris Hip Score of two patients in Magnum arm were failed to obtain.	51.2 units on a scale n=84 Participants • Preoperative Harris Hip Score of two patients in Magnum arm were failed to obtain.	51.7 units on a scale n=178 Participants • Preoperative Harris Hip Score of two patients in Magnum arm were failed to obtain.
EQ-5D	0.620 units on a scale n=95 Participants • Preoperative EQ-5D questionnaire was not completed by two subjects (one subject each arm).	0.647 units on a scale n=83 Participants • Preoperative EQ-5D questionnaire was not completed by two subjects (one subject each arm).	0.633 units on a scale n=178 Participants • Preoperative EQ-5D questionnaire was not completed by two subjects (one subject each arm).
UCLA Activity Score	3.1 units on a scale n=96 Participants	3.0 units on a scale n=84 Participants	3.0 units on a scale n=180 Participants

PRIMARY outcome

Timeframe: 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.

Hip Flexion Angle at 1 year postoperatively

Outcome measures

Measure	M2a Magnum n=94 Participants 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).	M2a Taper n=80 Participants 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).
Range of Motion	109.2 degrees Interval 70.0 to 130.0	110.2 degrees Interval 70.0 to 130.0

SECONDARY outcome

Timeframe: 3 month

Population: 3 patients in M2a Taper group were failed to obtain Metal Ion data at 3 month follow-up visit.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=96 Participants 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).	M2a Taper n=81 Participants 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).
Metal Ion	0.7 microgram/Litter Interval 0.0 to 2.3	0.9 microgram/Litter Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	M2a Magnum n=37 Participants 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).	M2a Taper n=25 Participants 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).
UCLA Activity Score	4.97 units on a scale Interval 3.0 to 9.0	4.8 units on a scale Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: 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.

number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)

Outcome measures

Measure	M2a Magnum n=51 Participants 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).	M2a Taper n=48 Participants 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).
Radiographic Assessment Acetabular Osteolysis	0 Participants	0 Participants
Radiographic Assessment Acetabular Radiolucency	0 Participants	0 Participants
Radiographic Assessment Stem Osteolysis	0 Participants	0 Participants
Radiographic Assessment Stem Radiolucency	2 Participants	7 Participants
Radiographic Assessment Heterotopic Ossification	2 Participants	1 Participants
Radiographic Assessment no abnormalities	47 Participants	40 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	M2a Magnum n=28 Participants 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).	M2a Taper n=22 Participants 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).
Harris Hip Score	96.3 units on a scale Interval 72.0 to 100.0	94.5 units on a scale Interval 64.0 to 100.0

SECONDARY outcome

Timeframe: 6 month

Population: 4 patients in M2a Taper group were failed to obtain Metal Ion data at 6 month follow-up visit.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=96 Participants 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).	M2a Taper n=80 Participants 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).
Metal Ion	0.9 microgram/Litter Interval 0.0 to 5.1	1.2 microgram/Litter Interval 0.0 to 8.9

SECONDARY outcome

Timeframe: 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.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=89 Participants 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).	M2a Taper n=75 Participants 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).
Metal Ion	1.2 microgram/Litter Interval 0.0 to 12.9	1.8 microgram/Litter Interval 0.0 to 15.4

SECONDARY outcome

Timeframe: 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.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=84 Participants 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).	M2a Taper n=74 Participants 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).
Metal Ion	1.2 microgram/Litter Interval 0.13 to 6.3	2.0 microgram/Litter Interval 0.2 to 11.0

SECONDARY outcome

Timeframe: 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.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=75 Participants 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).	M2a Taper n=65 Participants 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).
Metal Ion	0.98 microgram/Litter Interval 0.0 to 4.9	2.9 microgram/Litter Interval 0.0 to 44.0

SECONDARY outcome

Timeframe: 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.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=46 Participants 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).	M2a Taper n=38 Participants 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).
Metal Ion	1.09 microgram/Litter Interval 0.11 to 4.0	3.1 microgram/Litter Interval 0.0 to 22.0

SECONDARY outcome

Timeframe: 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.

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Outcome measures

Measure	M2a Magnum n=63 Participants 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).	M2a Taper n=54 Participants 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).
Metal Ion	1.07 microgram/Litter Interval 0.11 to 7.6	3.8 microgram/Litter Interval 0.16 to 71.0

Adverse Events

M2a Magnum

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

M2a Taper

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Measure	M2a Magnum n=96 participants at risk 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).	M2a Taper n=84 participants at risk 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).
Musculoskeletal and connective tissue disorders Revision due to Adverse Reaction to Metal Debris	1.0% 1/96 • Number of events 1 • 5 years	0.00% 0/84 • 5 years
Musculoskeletal and connective tissue disorders Femoral Epicondyle Fracture	0.00% 0/96 • 5 years	1.2% 1/84 • Number of events 1 • 5 years

Other adverse events

Measure	M2a Magnum n=96 participants at risk 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).	M2a Taper n=84 participants at risk 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).
Musculoskeletal and connective tissue disorders Dislocation	0.00% 0/96 • 5 years	3.6% 3/84 • Number of events 3 • 5 years
Vascular disorders Cerebral Infarction	1.0% 1/96 • Number of events 1 • 5 years	0.00% 0/84 • 5 years
Surgical and medical procedures Intra-operative fracture	1.0% 1/96 • Number of events 1 • 5 years	0.00% 0/84 • 5 years

Additional Information

Manager of Clinical Affairs

Zimmer Biomet G.K.

Phone: +81-3-6402-6610

Email: takahito.nakai@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place