Trial Outcomes & Findings for NexGen TM Tibia Clinical Outcomes Study (NCT NCT03272373)

Last Updated: 2024-12-30

Results Overview

Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of \>0.5mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

2 years

Results posted on

2024-12-30

Participant Flow

Unit of analysis: Knees

Participant milestones

Participant milestones
Measure	NexGen TM Monoblock Tibia NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty
Overall Study STARTED	104 110	56 63
Overall Study COMPLETED	83 89	48 55
Overall Study NOT COMPLETED	21 21	8 8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NexGen TM Tibia Clinical Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NexGen TM Monoblock Tibia n=110 Knees NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia n=63 Knees NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty	Total n=173 Knees Total of all reporting groups
Age, Continuous	62.60 years STANDARD_DEVIATION 7.78 • n=148 Knees	61.37 years STANDARD_DEVIATION 8.14 • n=147 Knees	62.15 years STANDARD_DEVIATION 7.91 • n=520 Knees
Sex: Female, Male Female	66 Knees n=148 Knees	36 Knees n=147 Knees	102 Knees n=520 Knees
Sex: Female, Male Male	44 Knees n=148 Knees	27 Knees n=147 Knees	71 Knees n=520 Knees
Race/Ethnicity, Customized African American or Black	9 Knees n=148 Knees	0 Knees n=147 Knees	9 Knees n=520 Knees
Race/Ethnicity, Customized Asian	1 Knees n=148 Knees	0 Knees n=147 Knees	1 Knees n=520 Knees
Race/Ethnicity, Customized Hispanic or Latino	19 Knees n=148 Knees	4 Knees n=147 Knees	23 Knees n=520 Knees
Race/Ethnicity, Customized White	69 Knees n=148 Knees	59 Knees n=147 Knees	128 Knees n=520 Knees
Race/Ethnicity, Customized Not Recorded	12 Knees n=148 Knees	0 Knees n=147 Knees	12 Knees n=520 Knees
Region of Enrollment United States	110 Knees n=148 Knees	63 Knees n=147 Knees	173 Knees n=520 Knees

PRIMARY outcome

Timeframe: 2 years

Population: Monoblock: 77 participants (83 knees) had radiographs analyzed at the 2 year follow-up interval. Modular: 48 participants (55 knees) had radiographs analyzed at the 2 year follow-up interval.

Outcome measures

Outcome measures
Measure	NexGen TM Monoblock Tibia n=83 Knees NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia n=55 Knees NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty
Radiograph Assessment of Progressive Tibial Radiolucencies Absent	82 Knees	55 Knees
Radiograph Assessment of Progressive Tibial Radiolucencies Present	0 Knees	0 Knees
Radiograph Assessment of Progressive Tibial Radiolucencies Unable to assess	1 Knees	0 Knees

SECONDARY outcome

Timeframe: 2 years

Population: Monoblock: 83 participants (89 knees) completed the Oxford Knee Score (OKS) at the 2 year interval. Modular: 46 participants (52 knees) completed the Oxford Knee Score (OKS) at the 2 year interval. Oxford Knee Scores above 41 are considered excellent and scores from 34 to 41 are considered good. The endpoint was designed to distinguish scores above 38. Reference: Murray et al. (2007). The use of the Oxford hip and knee scores. Bone \& Joint Journal, 89(8), 1010-1014

The Oxford Knee Score is a patient completed 12 question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The maximum score is 48 points (best) and the minimum score is 0 points (worst).

Outcome measures

Outcome measures
Measure	NexGen TM Monoblock Tibia n=89 Knees NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia n=52 Knees NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty
Oxford Knee Score OKS >38	64 Knees	47 Knees
Oxford Knee Score OKS <=38	25 Knees	5 Knees

SECONDARY outcome

Timeframe: 2 years

Population: A revision is when the study implant is removed/revised due to an adverse event. Of the 110 knees that received the NexGen TM Monoblock Tibia implant, there were 2 reported revisions. Of the 63 knees that received the NexGen TM Modular Tibia implant, there were 0 reported revisions

Rate of the number of revisions for any reason

Outcome measures

Outcome measures
Measure	NexGen TM Monoblock Tibia n=110 Knees NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia n=63 Knees NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty
Revision Rate Number of knees not revised	108 Knees	63 Knees
Revision Rate Number of knees revised	2 Knees	0 Knees

Adverse Events

NexGen TM Monoblock Tibia

Serious events: 10 serious events

Other events: 39 other events

Deaths: 2 deaths

NexGen TM Modular Tibia

Serious events: 7 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NexGen TM Monoblock Tibia n=104 participants at risk NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia n=56 participants at risk NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty
Cardiac disorders Cardiovascular	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Endocrine disorders Endocrine	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Gastrointestinal disorders Gastrointestinal	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Renal and urinary disorders Genitourinary/Renal	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Musculoskeletal (not study knee)	2.9% 3/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Nervous system disorders Neurological	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Contralateral Knee Replacement (UKA or TKA)	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	5.4% 3/56 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Injury, poisoning and procedural complications Traumatic Injury (not study knee)	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Infections and infestations Deep Wound Infection	1.9% 2/104 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
General disorders Other General Adverse Event	2.9% 3/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.

Other adverse events

Additional Information

Director of Clinical Operations

Zimmer Biomet

Phone: 800-613-6131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any proposed publication or presentation will be submitted to sponsor for review (not for approval or disapproval) at least thirty (30) days prior to submission for publication or presentation. If proposed publication or presentation contains patentable subject matter that needs protection, sponsor may request PI to delay the publication or presentation for an additional ninety (90) days to allow Sponsor to file a patent application.
Publication restrictions are in place

Restriction type: OTHER

Measure	NexGen TM Monoblock Tibia n=104 participants at risk NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty	NexGen TM Modular Tibia n=56 participants at risk NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty
Cardiac disorders Cardiovascular	4.8% 5/104 • Number of events 5 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Nervous system disorders Neurological	1.9% 2/104 • Number of events 5 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncological	1.9% 2/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory	1.9% 2/104 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Surgical and medical procedures Contralateral Knee Replacement (UKA or TKA)	2.9% 3/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	8.9% 5/56 • Number of events 5 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Vascular disorders Vascular/DVT	2.9% 3/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Skin and subcutaneous tissue disorders Dermatological	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Endocrine disorders Endocrine	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Stiffness/Limited ROM (progressive/persistent)	1.9% 2/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	3.6% 2/56 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Renal and urinary disorders Genitourinary/Renal	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Skin and subcutaneous tissue disorders Wound Dehiscence	1.9% 2/104 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Skin and subcutaneous tissue disorders Wound Drainage	0.96% 1/104 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Clicking/Popping/Crepitus/Grinding	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	7.1% 4/56 • Number of events 4 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Pain (progressive/persistent)	3.8% 4/104 • Number of events 4 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	16.1% 9/56 • Number of events 10 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Baker's Cyst	0.96% 1/104 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Articular Surface Dislocation/Disassociation	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Skin and subcutaneous tissue disorders Cellulitis/Redness/Blistering	1.9% 2/104 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	1.8% 1/56 • Number of events 1 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Effusion/Swelling/Edema	0.00% 0/104 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	5.4% 3/56 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Injury, poisoning and procedural complications Traumatic Injury (study knee)	1.9% 2/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	5.4% 3/56 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Infections and infestations Infection (not study knee)	2.9% 3/104 • Number of events 3 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
General disorders Other General Adverse Event	3.8% 4/104 • Number of events 6 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
Musculoskeletal and connective tissue disorders Musculoskeletal (not study knee)*	15.4% 16/104 • Number of events 24 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	21.4% 12/56 • Number of events 20 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.
General disorders Other Ipsilateral Knee Related Adverse Event	1.9% 2/104 • Number of events 2 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.	0.00% 0/56 • Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the study.