An interventional study of Triathlon TS Knee System in Arthroplasty, Replacement, Knee, sponsored by Stryker Orthopaedics. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by Stryker Orthopaedics · Not applicable, Interventional, and Treatment
This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.
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Exclusion Criteria:
Triathlon TS Knee System
Device: Triathlon TS Knee System
Total knee replacement for revision cases
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
Time frame: pre-op, 2 years
Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.
Time frame: 2 years, 5 years
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to \> 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years with all results in only one category of \< 5 degrees. The higher the number of degrees or mm measured the more instability in the knee.
Time frame: 2 year and 5 year postoperative
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.
Time frame: 2 year and 5 year postoperative
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: pre-op, 1, 2, 5 years
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.
Time frame: 1, 2, 5 years
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Revision was defined as the removal of either the femoral component or the tibial baseplate component.
Time frame: 5 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-op, 1, 2, 5 years
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
Time frame: pre-op, 1, 2, 5 years
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: pre-op, 1, 2, 5 years
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Time frame: pre-op, 1,2, 5 year
| Milestone | Triathlon TS Knee |
|---|---|
| Started | 180 |
| Completed | 130 |
| Not completed | 50 |
| Withdrew: Death | 5 |
| Withdrew: Lost to follow-up | 14 |
| Withdrew: Withdrawal by subject | 17 |
| Withdrew: No 2 yr. knee society score data | 4 |
| Withdrew: 2 yr. knee society score not calculable | 1 |
| Withdrew: Subject terminated | 2 |
| Withdrew: Revision | 7 |
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
| units on a scale | Triathlon TS Knee |
|---|---|
| KSS Pain/motion score preoperative | 39.81 ± 21.12 |
| KSS Pain/motion score 2 yrs. | 83.97 ± 15.95 |
| KSS Function score preoperative | 41.43 ± 23.09 |
| KSS Function score 2 yrs. | 72.90 ± 25.12 |
| Combined KSS score preoperative | 82.96 ± 34.96 |
| Combined KSS score 2 yrs. | 157.05 ± 36.13 |
This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.
| units on a scale | Joint Line Restoration (JLR) ≤ 5 mm | Joint Line Restoration (JLR) > 5 mm |
|---|---|---|
| KSS Function Score at 2yr | 75.31 ± 22.81 | 70.00 ± 25.02 |
| KSS Function Score at 5yr | 66.82 ± 23.31 | 71.36 ± 26.78 |
Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to \> 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years with all results in only one category of \< 5 degrees. The higher the number of degrees or mm measured the more instability in the knee.
| Knees | Joint Line Restoration (JLR) ≤ 5 mm | Joint Line Restoration (JLR) > 5mm |
|---|---|---|
| Knee Stability AP < 5mm at 2 years | 47 | 29 |
| Knee Stability AP 5-10mm at 2 years | 2 | 3 |
| Knee Stability AP < 5mm at 5 years | 30 | 21 |
| Knee Stability AP 5-10mm at 5 years | 1 | 1 |
| Knee Stability ML< 5 degrees at 2 years | 49 | 32 |
| Knee Stability ML < 5 degrees at 5 years | 31 | 22 |
Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.
| Knees | Joint Line Restoration (JLR) ≤ 5 mm | Joint Line Restoration (JLR) > 5 mm |
|---|---|---|
| Anterior Knee Pain Absent at 2 yrs | 45 | 28 |
| Anterior Knee Pain Present at 2 yrs. | 5 | 4 |
| Anterior Knee Pain Absent at 5 yrs. | 26 | 20 |
| Anterior Knee Pain Present at 5 yrs. | 7 | 2 |
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
| units on a scale | Triathlon TS Knee |
|---|---|
| SF-36 Physical Score Preoperative | 32.43 ± 8.07 |
| SF-36 Physical Score 1 year | 41.30 ± 10.49 |
| SF-36 Physical Score 2 year | 40.55 ± 11.60 |
| SF-36 Physical Score 5 year | 38.42 ± 10.44 |
| SF-36 Mental Score Preoperative | 45.85 ± 14.81 |
| SF-36 Mental Score 1 year | 52.57 ± 12.33 |
| SF-36 Mental Score 2 year | 52.42 ± 11.99 |
| SF-36 Mental Score 5 years | 54.07 ± 11.81 |
The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.
| Knees | Triathlon TS Knee |
|---|---|
| Radiographically unstable at 1 year | 2 |
| Radiographically unstable at 2 year | 0 |
| Radiographically unstable at 5 year | 0 |
Revision was defined as the removal of either the femoral component or the tibial baseplate component.
| Knees | Triathlon TS Knee |
|---|---|
| Aseptic Loosening | 5 |
| Septic Loosening | 9 |
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
| units on a scale | Triathlon TS Knee |
|---|---|
| KOOS Pain Preoperative | 41.51 ± 18.91 |
| KOOS Pain 1 year | 75.09 ± 21.55 |
| KOOS Pain 2 year | 74.67 ± 21.36 |
| KOOS Pain 5 year | 73.95 ± 21.31 |
| KOOS Symptoms Preoperative | 43.39 ± 18.93 |
| KOOS Symptoms 1 year | 73.02 ± 21.02 |
| KOOS Symptoms 2 year | 72.95 ± 19.11 |
| KOOS Symptoms 5 year | 75.88 ± 17.25 |
| KOOS Daily Living Preoperative | 45.56 ± 20.41 |
| KOOS Daily Living 1 year | 76.43 ± 21.19 |
| KOOS Daily Living 2 year | 76.17 ± 21.83 |
| KOOS Daily Living 5 year | 74.99 ± 20.34 |
| KOOS Function Sports and Recreational Preoperative | 12.56 ± 19.95 |
| KOOS Function Sports and Recreational 1 year | 44.10 ± 34.39 |
| KOOS Function Sports and Recreational 2 year | 41.86 ± 33.26 |
| KOOS Function Sports and Recreational 5 year | 42.77 ± 43.41 |
| KOOS Quality of Life Preoperative | 18.06 ± 17.90 |
| KOOS Quality of Life 1 year | 55.99 ± 28.20 |
| KOOS Quality of Life 2 year | 55.74 ± 27.71 |
| KOOS Quality of Life 5 year | 57.37 ± 27.56 |
The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
| units on a scale | Triathlon TS Knee |
|---|---|
| HSS Patella Score Preoperative | 45.09 ± 18.43 |
| HSS Patella Score 1 year | 76.68 ± 21.48 |
| HSS Patella Score 2 year | 80.08 ± 19.31 |
| HSS Patella Score 5 year | 78.56 ± 20.24 |
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
| units on a scale | Triathlon TS Knee |
|---|---|
| LEAS Score Preoperative | 7.80 ± 2.86 |
| LEAS Score 1 year | 9.65 ± 3.18 |
| LEAS Score 2 year | 9.60 ± 3.26 |
| LEAS Score 5 year | 9.75 ± 3.39 |
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
| units on a scale | Triathlon TS Knee |
|---|---|
| Pain Motion Mean Preoperative | 39.81 ± 21.12 |
| Pain Motion Mean 1 year | 85.45 ± 15.14 |
| Pain Motion Mean 2 year | 83.97 ± 15.95 |
| Pain Motion Mean 5 year | 82.06 ± 17.24 |
| Function Mean Preoperative | 41.43 ± 23.09 |
| Function Mean 1 year | 74.18 ± 24.00 |
| Function Mean 2 year | 72.90 ± 25.12 |
| Function Mean 5 year | 70.71 ± 26.51 |
Collected over This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Operative Adverse Events | 0/181 (0%) | 37/181 (20.4%) | 59/181 (32.6%) |
| Non-Operative Adverse Events | 7/180 (3.9%) | 40/180 (22.2%) | 0/180 (0%) |
| Event | Operative Adverse Events | Non-Operative Adverse Events |
|---|---|---|
| Operative SiteMusculoskeletal and connective tissue disorders | 24/181 | — |
| Operative SiteInfections and infestations | 15/181 | — |
| Non-operative SiteCardiac disorders | — | 11/180 |
| Non-operative SiteMusculoskeletal and connective tissue disorders | — | 10/180 |
| Non-operative SiteInfections and infestations | — | 7/180 |
| Non-operative SiteGastrointestinal disorders | — | 5/180 |
| Non-operative SiteRenal and urinary disorders | — | 5/180 |
| Non-operative SiteRespiratory, thoracic and mediastinal disorders | — | 5/180 |
| Non-operative SiteVascular disorders | — | 5/180 |
| Operative SiteInjury, poisoning and procedural complications | 4/181 | — |
| Event | Operative Adverse Events | Non-Operative Adverse Events |
|---|---|---|
| Operative SiteMusculoskeletal and connective tissue disorders | 59/181 | — |
Participants who were censored are not included in baseline analysis.
| Age, Continuous(years) | Triathlon TS Knee |
|---|---|
| Mean | 67.25 ± 9.59 |
| Sex: Female, Male(Participants) | Triathlon TS Knee |
|---|---|
| Female | 99 |
| Male | 81 |
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Stryker Orthopaedics