Trial Outcomes & Findings for A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System (NCT NCT02036931)

NCT ID: NCT02036931

Last Updated: 2025-12-19

Results Overview

The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS 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, o-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
• Target enrollment: 162 participants
• Primary outcome timeframe: Pre-operative,1, 2, and 5 years postoperatively
• Results posted on: 2025-12-19

Participant Flow

Participant milestones

Measure	Metal on Polyethylene Articulation G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene Articulation G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic Articulation G7 cup with Ceramic on Ceramic articulation (COC)
Overall Study STARTED	96	37	29
Overall Study COMPLETED	37	15	10
Overall Study NOT COMPLETED	59	22	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metal on Polyethylene Articulation n=96 Participants G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene Articulation n=37 Participants G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic Articulation n=29 Participants G7 cup with Ceramic on Ceramic articulation (COC)	Total n=162 Participants Total of all reporting groups
Age, Continuous	68.8 Years n=96 Participants	61 Years n=37 Participants	61 Years n=29 Participants	66 Years n=162 Participants
Sex: Female, Male Female	46 Participants n=96 Participants	26 Participants n=37 Participants	7 Participants n=29 Participants	79 Participants n=162 Participants
Sex: Female, Male Male	50 Participants n=96 Participants	11 Participants n=37 Participants	22 Participants n=29 Participants	83 Participants n=162 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Harris Hip Score	45.8 Scores STANDARD_DEVIATION 16.7 • n=91 Participants • Scores at preop visit are available for fewer patients than total enrollment due to retrospective data collection.	43.1 Scores STANDARD_DEVIATION 12.6 • n=37 Participants • Scores at preop visit are available for fewer patients than total enrollment due to retrospective data collection.	50.7 Scores STANDARD_DEVIATION 15.4 • n=29 Participants • Scores at preop visit are available for fewer patients than total enrollment due to retrospective data collection.	46.1 Scores STANDARD_DEVIATION 15.7 • n=157 Participants • Scores at preop visit are available for fewer patients than total enrollment due to retrospective data collection.

PRIMARY outcome

Timeframe: Pre-operative,1, 2, and 5 years postoperatively

Population: The number of participants decreased around the 5-year visit due to substantial patient loss at certain sites.

The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS 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, o-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.

Outcome measures

Measure	Metal on Polyethylene articulation n=91 Participants G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene articulation n=37 Participants G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic articulation n=29 Participants G7 cup with Ceramic on Ceramic articulation (COC)
Harris Hip Score Pre-op	45.8 Score Standard Deviation 16.7	43.1 Score Standard Deviation 12.6	50.7 Score Standard Deviation 15.4
Harris Hip Score 1 Year	95.4 Score Standard Deviation 7.4	94.2 Score Standard Deviation 7.3	92.8 Score Standard Deviation 10.0
Harris Hip Score 2 Year	96.1 Score Standard Deviation 6.4	93.4 Score Standard Deviation 9.5	94.3 Score Standard Deviation 8.7
Harris Hip Score 5 Year	94.8 Score Standard Deviation 7.1	91.7 Score Standard Deviation 6.8	94.1 Score Standard Deviation 7.8

SECONDARY outcome

Timeframe: Pre-op, 1, 2, and 5 years postoperatively

Population: The number of participants decreased around the 5-year visit due to substantial patient loss at certain sites.

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

Measure	Metal on Polyethylene articulation n=87 Participants G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene articulation n=37 Participants G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic articulation n=26 Participants G7 cup with Ceramic on Ceramic articulation (COC)
Oxford Hip Score Pre-op	19.6 Score Standard Deviation 9.1	16.2 Score Standard Deviation 6.3	22.7 Score Standard Deviation 9.0
Oxford Hip Score 1 Year	46.1 Score Standard Deviation 3.3	45.4 Score Standard Deviation 3.3	45.4 Score Standard Deviation 2.9
Oxford Hip Score 2 Year	46.7 Score Standard Deviation 2.4	45.2 Score Standard Deviation 5.1	44.4 Score Standard Deviation 6.1
Oxford Hip Score 5 Year	46.5 Score Standard Deviation 2.4	45.8 Score Standard Deviation 2.4	43.4 Score Standard Deviation 7.9

SECONDARY outcome

Timeframe: 7 and 10 Year post-operative

Population: The K-M survival for CoP and CoC groups were only calculated up to 7 years because less than 20 cases remained at risk after that timepoint, which was below the level of detection to calculate a reliable Kaplan Meier estimate.

Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.

Outcome measures

Measure	Metal on Polyethylene articulation n=41 Participants G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene articulation n=23 Participants G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic articulation n=27 Participants G7 cup with Ceramic on Ceramic articulation (COC)
Survivorship 7 Year	0.9762 proportion of participants Interval 0.8428 to 0.9966	0.9697 proportion of participants Interval 0.8037 to 0.9957	1.0000 proportion of participants Interval 1.0 to 1.0
Survivorship 10 Year	0.9762 proportion of participants Interval 0.8428 to 0.9966	NA proportion of participants Below the level of detection (Only 16 cases remained at risk, which was insufficient \[\<20 cases\] to calculate a Kaplan Meier estimate).	NA proportion of participants Below the level of detection (Only 13 cases remained at risk, which was insufficient \[\<20 cases\] to calculate a Kaplan Meier estimate).

SECONDARY outcome

Timeframe: 10 Year post-operative

Population: A Kaplan-Meier survival analysis was performed for all cases including 39 from MoP arm, 16 from CoP arm, 13 from CoC arm.

Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.

Outcome measures

Measure	Metal on Polyethylene articulation n=68 Participants G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene articulation G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic articulation G7 cup with Ceramic on Ceramic articulation (COC)
Survivorship	0.9818 proportion of participants Interval 0.9277 to 0.9955	—	—

SECONDARY outcome

Timeframe: Immediate post-op, 3 months, 1, 2, and 5 years

Population: The number of cases decreased around 5 years because two sites discontinued the study.

All radiographs have been reviewed by the investigators at each site in order to detect and report any abnormal and significant findings (including adverse events). The change from the angle of inclination between the different follow-ups is shown in the table.

Outcome measures

Measure	Metal on Polyethylene articulation n=96 Participants G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene articulation n=37 Participants G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic articulation n=29 Participants G7 cup with Ceramic on Ceramic articulation (COC)
Radiographic Evaluation 2 Years	42.7 Degree Standard Deviation 5.9	42.0 Degree Standard Deviation 5.4	37.6 Degree Standard Deviation 6.1
Radiographic Evaluation 5 Years	39.6 Degree Standard Deviation 4.3	41.8 Degree Standard Deviation 4.0	38.0 Degree Standard Deviation 6.9
Radiographic Evaluation Immediate Post-Op	43.2 Degree Standard Deviation 5.8	41.9 Degree Standard Deviation 5.7	37.2 Degree Standard Deviation 6.1
Radiographic Evaluation 3 Months	42.8 Degree Standard Deviation 5.4	41.8 Degree Standard Deviation 5.5	37.2 Degree Standard Deviation 6.1
Radiographic Evaluation 1 Year	42.3 Degree Standard Deviation 5.7	42.4 Degree Standard Deviation 5.1	37.3 Degree Standard Deviation 6.3

Adverse Events

Metal on Polyethylene Articulation

Serious events: 19 serious events

Other events: 4 other events

Deaths: 5 deaths

Ceramic on Polyethylene Articulation

Serious events: 9 serious events

Other events: 0 other events

Deaths: 1 deaths

Ceramic on Ceramic Articulation

Serious events: 13 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Metal on Polyethylene Articulation n=96 participants at risk G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene Articulation n=37 participants at risk G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic Articulation n=29 participants at risk G7 cup with Ceramic on Ceramic articulation (COC)
Musculoskeletal and connective tissue disorders Revision	1.0% 1/96 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	2.7% 1/37 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/29 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
Musculoskeletal and connective tissue disorders Dislocation	2.1% 2/96 • Number of events 2 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	2.7% 1/37 • Number of events 2 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/29 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
General disorders Death (unknown cause)	5.2% 5/96 • Number of events 5 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	2.7% 1/37 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	10.3% 3/29 • Number of events 3 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
Infections and infestations Infection	1.0% 1/96 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	5.4% 2/37 • Number of events 2 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	6.9% 2/29 • Number of events 2 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
Musculoskeletal and connective tissue disorders Liner wear	1.0% 1/96 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/37 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/29 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
Blood and lymphatic system disorders Deep vein thrombosis	0.00% 0/96 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/37 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	3.4% 1/29 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
Musculoskeletal and connective tissue disorders Musculoskeletal / Soft tissue	0.00% 0/96 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/37 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	3.4% 1/29 • Number of events 1 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.
General disorders General AE	9.4% 9/96 • Number of events 9 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	10.8% 4/37 • Number of events 5 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	20.7% 6/29 • Number of events 11 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.

Other adverse events

Measure	Metal on Polyethylene Articulation n=96 participants at risk G7 cup with Metal on Polyethylene articulation (MOP)	Ceramic on Polyethylene Articulation n=37 participants at risk G7 cup with Ceramic on Polyethylene articulation (COP)	Ceramic on Ceramic Articulation n=29 participants at risk G7 cup with Ceramic on Ceramic articulation (COC)
Musculoskeletal and connective tissue disorders Adverse Device Effects (ADE): Musculoskeletal and connective tissue disorders	4.2% 4/96 • Number of events 4 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/37 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.	0.00% 0/29 • Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up. Adverse Events and Adverse Device Effects were documented during the whole course of the study.

Additional Information

Oliver Marti

Zimmer Biomet

Phone: +41 79 576 31 98

Email: oliver.marti1@zimmerbiomet.com

Results disclosure agreements

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