Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle, Moderate Valgus, Varus, or Flexion Deformities, Osteoarthritis, Polyarthritis, Post-traumatic Loss of Joint Configuration, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
Detailed description
This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device, and adverse event data. This clinical study will include the NexGen TM Monoblock Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years. The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol. The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon: * No revisions for any reason * Oxford Knee Score \>38
Interventions
DEVICENexGen TM Monoblock Tibia
Primary cementless tibia total knee arthroplasty
DEVICENexGen TM Modular Tibia
Primary cementless tibia total knee arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 single arms being analyzed separately
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at least 18 years of age. 2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2. Collagen disorders and/or avascular necrosis of the femoral condyle. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. Moderate valgus, varus, or flexion deformities. 5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee. 3. Patient has participated in the study-related Informed Consent process. 4. Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form. 5. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form. 6. Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.
Exclusion criteria
1. Previous history of infection in the affected joint. 2. Active local or systemic infection that may affect the prosthetic joint. 3. Insufficient bone stock on femoral or tibial surfaces. 4. Skeletal immaturity. 5. Neuropathic arthropathy. 6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb. 7. A stable, painless arthrodesis in a satisfactory functional position. 8. Severe instability secondary to the absence of collateral ligament integrity. 9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin. 10. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee. 11. Patient is currently participating in any other surgical intervention studies or pain management studies. 12. Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.). 13. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiograph Assessment of Progressive Tibial Radiolucencies | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score | 2 years | 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). |
| Revision Rate | 2 years | Rate of the number of revisions for any reason |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NexGen TM Monoblock Tibia NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty | 104 |
| NexGen TM Monoblock Tibia NexGen Trabecular Metal (TM) Monoblock Tibia used in primary cementless total knee arthroplasty | 110 |
| NexGen TM Modular Tibia NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty | 56 |
| NexGen TM Modular Tibia NexGen Trabecular Metal (TM) Modular Tibia used in primary cementless total knee arthroplasty | 63 |
| Total | 333 |
Baseline characteristics
| Characteristic | NexGen TM Modular Tibia | Total | NexGen TM Monoblock Tibia |
|---|---|---|---|
| Age, Continuous | 61.37 years STANDARD_DEVIATION 8.14 | 62.15 years STANDARD_DEVIATION 7.91 | 62.60 years STANDARD_DEVIATION 7.78 |
| Race/Ethnicity, Customized African American or Black | 0 Knees | 9 Knees | 9 Knees |
| Race/Ethnicity, Customized Asian | 0 Knees | 1 Knees | 1 Knees |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Knees | 23 Knees | 19 Knees |
| Race/Ethnicity, Customized Not Recorded | 0 Knees | 12 Knees | 12 Knees |
| Race/Ethnicity, Customized White | 59 Knees | 128 Knees | 69 Knees |
| Region of Enrollment United States | 63 Knees | 173 Knees | 110 Knees |
| Sex: Female, Male Female | 36 Knees | 102 Knees | 66 Knees |
| Sex: Female, Male Male | 27 Knees | 71 Knees | 44 Knees |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 104 | 0 / 56 |
| other Total, other adverse events | 39 / 104 | 28 / 56 |
| serious Total, serious adverse events | 10 / 104 | 7 / 56 |
Outcome results
Primary
Radiograph Assessment of Progressive Tibial Radiolucencies
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NexGen TM Monoblock Tibia | Radiograph Assessment of Progressive Tibial Radiolucencies | Absent | 82 Knees |
| NexGen TM Monoblock Tibia | Radiograph Assessment of Progressive Tibial Radiolucencies | Present | 0 Knees |
| NexGen TM Monoblock Tibia | Radiograph Assessment of Progressive Tibial Radiolucencies | Unable to assess | 1 Knees |
| NexGen TM Modular Tibia | Radiograph Assessment of Progressive Tibial Radiolucencies | Absent | 55 Knees |
| NexGen TM Modular Tibia | Radiograph Assessment of Progressive Tibial Radiolucencies | Present | 0 Knees |
| NexGen TM Modular Tibia | Radiograph Assessment of Progressive Tibial Radiolucencies | Unable to assess | 0 Knees |
Secondary
Oxford Knee Score
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).
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NexGen TM Monoblock Tibia | Oxford Knee Score | OKS >38 | 64 Knees |
| NexGen TM Monoblock Tibia | Oxford Knee Score | OKS <=38 | 25 Knees |
| NexGen TM Modular Tibia | Oxford Knee Score | OKS >38 | 47 Knees |
| NexGen TM Modular Tibia | Oxford Knee Score | OKS <=38 | 5 Knees |
Secondary
Revision Rate
Rate of the number of revisions for any reason
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NexGen TM Monoblock Tibia | Revision Rate | Number of knees revised | 2 Knees |
| NexGen TM Monoblock Tibia | Revision Rate | Number of knees not revised | 108 Knees |
| NexGen TM Modular Tibia | Revision Rate | Number of knees not revised | 63 Knees |
| NexGen TM Modular Tibia | Revision Rate | Number of knees revised | 0 Knees |