Trial Outcomes & Findings for A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty (NCT NCT00754520)

Last Updated: 2024-10-02

Results Overview

CCS is defined as: a. Total Harris Hip Score \> 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following: 1. Migration \< 4 mm, and 2. Change in angle of inclination \< 4o, and 3. Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following: 1\. Subsidence \< 5 mm, and 2. Absence of osteolysis. The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70

Recruitment status

COMPLETED

Study phase

Target enrollment

213 participants

Primary outcome timeframe

2 years post-operatively

Results posted on

2024-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Ceramic On Metal Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Overall Study STARTED	111	102
Overall Study COMPLETED	56	53
Overall Study NOT COMPLETED	55	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceramic On Metal n=111 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=102 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.	Total n=213 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 7 • n=111 Participants	65.3 years STANDARD_DEVIATION 7.2 • n=102 Participants	65.2 years STANDARD_DEVIATION 7.1 • n=213 Participants
Sex: Female, Male Female	38 Participants n=111 Participants	40 Participants n=102 Participants	78 Participants n=213 Participants
Sex: Female, Male Male	73 Participants n=111 Participants	62 Participants n=102 Participants	135 Participants n=213 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Finland	30 participants n=111 Participants	22 participants n=102 Participants	52 participants n=213 Participants
Region of Enrollment United Kingdom	81 participants n=111 Participants	80 participants n=102 Participants	161 participants n=213 Participants

PRIMARY outcome

Timeframe: 2 years post-operatively

Population: Due to a lack of radiographic evaluation data, the overall number of participants analyzed is smaller than the actual number enrolled.

Outcome measures

Outcome measures
Measure	Ceramic On Metal n=75 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=77 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Composite Clinical Success (CCS) Rate as Defined in the Protocol	59 Participants	63 Participants

SECONDARY outcome

Timeframe: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively

Population: 2 patients were not included in analysis due to receiving a different articulation (not the study device). Other than that, the number of participants decreased over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason.

The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27.

Outcome measures

Outcome measures
Measure	Ceramic On Metal n=108 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=102 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Oxford Hip Score 2 years postoperative	46.6 units on a scale Standard Deviation 2.7	45.9 units on a scale Standard Deviation 4.5
Oxford Hip Score preoperative	22.7 units on a scale Standard Deviation 6.9	22.1 units on a scale Standard Deviation 7.3
Oxford Hip Score 6 weeks postoperative	37.3 units on a scale Standard Deviation 6.8	39.0 units on a scale Standard Deviation 6.7
Oxford Hip Score 6 months postoperative	45.0 units on a scale Standard Deviation 4.3	44.8 units on a scale Standard Deviation 5.2
Oxford Hip Score 1 year postoperative	46.0 units on a scale Standard Deviation 3.8	46.1 units on a scale Standard Deviation 4.1
Oxford Hip Score 3 years postoperative	46.4 units on a scale Standard Deviation 3.5	45.9 units on a scale Standard Deviation 4.5
Oxford Hip Score 4 years postoperative	46.8 units on a scale Standard Deviation 2.7	46.0 units on a scale Standard Deviation 4.2
Oxford Hip Score 5 years postoperative	46.1 units on a scale Standard Deviation 3.1	45.9 units on a scale Standard Deviation 3.8
Oxford Hip Score 10 years postoperative	44.0 units on a scale Standard Deviation 7.9	42.1 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.

Outcome measures

Outcome measures
Measure	Ceramic On Metal n=108 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=102 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Womac Score Stiffness 6 weeks post-operatively	1.9 Units on a scale Standard Deviation 1.3	1.8 Units on a scale Standard Deviation 1.3
Womac Score Stiffness 6 months post-operatively	0.6 Units on a scale Standard Deviation 1.0	0.7 Units on a scale Standard Deviation 1.2
Womac Score Stiffness 1 year post-operatively	0.4 Units on a scale Standard Deviation 0.8	0.4 Units on a scale Standard Deviation 0.9
Womac Score Stiffness 2 year post-operatively	0.2 Units on a scale Standard Deviation 0.6	0.4 Units on a scale Standard Deviation 0.9
Womac Score Stiffness 3 year post-operatively	0.3 Units on a scale Standard Deviation 0.9	0.1 Units on a scale Standard Deviation 0.6
Womac Score Stiffness 4 year post-operatively	0.2 Units on a scale Standard Deviation 0.6	0.4 Units on a scale Standard Deviation 1.1
Womac Score Stiffness 5 year post-operatively	0.7 Units on a scale Standard Deviation 1.2	0.7 Units on a scale Standard Deviation 1.3
Womac Score Stiffness 10 year post-operatively	0.7 Units on a scale Standard Deviation 1.2	0.9 Units on a scale Standard Deviation 1.4
Womac Score ADL pre-operatively	32.1 Units on a scale Standard Deviation 10.6	33.7 Units on a scale Standard Deviation 9.3
Womac Score ADL 6 weeks post-operatively	12.6 Units on a scale Standard Deviation 9.4	11.1 Units on a scale Standard Deviation 10.0
Womac Score ADL 6 months post-operatively	3.8 Units on a scale Standard Deviation 5.4	5.0 Units on a scale Standard Deviation 7.7
Womac Score ADL 1 year post-operatively	3.2 Units on a scale Standard Deviation 7.9	3.8 Units on a scale Standard Deviation 6.8
Womac Score ADL 2 year post-operatively	2.7 Units on a scale Standard Deviation 5.9	3.4 Units on a scale Standard Deviation 6.6
Womac Score ADL 3 year post-operatively	2.9 Units on a scale Standard Deviation 6.8	2.7 Units on a scale Standard Deviation 5.9
Womac Score ADL 4 year post-operatively	2.5 Units on a scale Standard Deviation 5.1	2.7 Units on a scale Standard Deviation 5.5
Womac Score ADL 5 year post-operatively	3.5 Units on a scale Standard Deviation 5.8	4.3 Units on a scale Standard Deviation 7.6
Womac Score ADL 10 year post-operatively	5.1 Units on a scale Standard Deviation 7.6	5.6 Units on a scale Standard Deviation 8.8
Womac Score Pain pre-operatively	10.5 Units on a scale Standard Deviation 3.3	11.5 Units on a scale Standard Deviation 2.9
Womac Score Pain 6 weeks post-operatively	2.9 Units on a scale Standard Deviation 3.0	2.4 Units on a scale Standard Deviation 2.8
Womac Score Pain 6 months post-operatively	0.8 Units on a scale Standard Deviation 1.9	0.7 Units on a scale Standard Deviation 1.8
Womac Score Pain 1 year post-operatively	0.5 Units on a scale Standard Deviation 1.4	0.3 Units on a scale Standard Deviation 1.0
Womac Score Pain 2 year post-operatively	0.3 Units on a scale Standard Deviation 1.2	0.5 Units on a scale Standard Deviation 1.7
Womac Score Pain 3 year post-operatively	0.4 Units on a scale Standard Deviation 1.1	0.5 Units on a scale Standard Deviation 1.6
Womac Score Pain 4 year post-operatively	0.3 Units on a scale Standard Deviation 1.1	0.6 Units on a scale Standard Deviation 2.0
Womac Score Pain 5 year post-operatively	0.6 Units on a scale Standard Deviation 1.6	0.7 Units on a scale Standard Deviation 1.8
Womac Score Pain 10 year post-operatively	0.6 Units on a scale Standard Deviation 1.9	0.6 Units on a scale Standard Deviation 1.9
Womac Score Stiffness pre-operatively	4.0 Units on a scale Standard Deviation 1.3	4.1 Units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 6 months post-operatively, 1, 2, 3 and 5 years post-operatively

Population: Metal Ion analysis is only performed on a subset of the patients. Other than that, the number of participants fluctuates over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason.

Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.

Outcome measures

Outcome measures
Measure	Ceramic On Metal n=38 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=35 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Metal Ion Concentrations in Blood Chromium 6 months	-1.8 nmol/l Standard Deviation 16.9	1.9 nmol/l Standard Deviation 15.3
Metal Ion Concentrations in Blood Chromium 1 year	1.5 nmol/l Standard Deviation 25.4	17.5 nmol/l Standard Deviation 32.5
Metal Ion Concentrations in Blood Chromium 2 years	1.4 nmol/l Standard Deviation 13.9	18.8 nmol/l Standard Deviation 29.9
Metal Ion Concentrations in Blood Chromium 3 years	-15.3 nmol/l Standard Deviation 7.3	-13.4 nmol/l Standard Deviation 8.2
Metal Ion Concentrations in Blood Chromium 5 years	8.9 nmol/l Standard Deviation 29.3	19.1 nmol/l Standard Deviation 30.7
Metal Ion Concentrations in Blood Cobalt 6 months	8.8 nmol/l Standard Deviation 8.7	26.8 nmol/l Standard Deviation 25.1
Metal Ion Concentrations in Blood Cobalt 1 year	16.3 nmol/l Standard Deviation 28.3	41.4 nmol/l Standard Deviation 77.8
Metal Ion Concentrations in Blood Cobalt 2 years	12.3 nmol/l Standard Deviation 18.2	45.1 nmol/l Standard Deviation 45.5
Metal Ion Concentrations in Blood Cobalt 3 years	13.0 nmol/l Standard Deviation 19.6	57.5 nmol/l Standard Deviation 61.4
Metal Ion Concentrations in Blood Cobalt 5 years	17.7 nmol/l Standard Deviation 46.4	64.9 nmol/l Standard Deviation 64.0

SECONDARY outcome

Timeframe: 10 years post-op

Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.

Outcome measures

Outcome measures
Measure	Ceramic On Metal n=111 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=102 Participants Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Survivorship	99 Participants	88 Participants

Adverse Events

Ceramic On Metal

Serious events: 35 serious events

Other events: 0 other events

Deaths: 16 deaths

Metal on Metal

Serious events: 38 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Ceramic On Metal n=110 participants at risk Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.	Metal on Metal n=101 participants at risk Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.
Surgical and medical procedures Revision	10.9% 12/110 • Number of events 12 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.	13.9% 14/101 • Number of events 14 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.
General disorders Cancer	5.5% 6/110 • Number of events 7 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.	5.0% 5/101 • Number of events 5 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.
Cardiac disorders Cardiovascular problems	3.6% 4/110 • Number of events 4 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.	5.0% 5/101 • Number of events 5 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.
Musculoskeletal and connective tissue disorders Muculoskeletal problems	11.8% 13/110 • Number of events 13 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.	10.9% 11/101 • Number of events 11 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.
General disorders Other	4.5% 5/110 • Number of events 6 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.	5.9% 6/101 • Number of events 6 • From surgery until the last study visit at 10 years post-op. ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Project Lead

Zimmer Biomet

Phone: +31 62 395 6378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place