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This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.
Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.
Protocol Attached in documentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ShapeMatch Cutting Guides with Triathlon | Other | The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ShapeMatch Cutting Guides with Triathlon | Device | All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Location/Assessment of Alignment | Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees. | 3 months Post-Operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients were assessed and then placed in either Part A or Part B. Patients in Part B were invited to participate in the extension follow-up to 5-years.
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| ID | Title | Description |
|---|---|---|
| FG000 | ShapeMatch® Cutting Guides With Triathlon® | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline measurements are only available for participants who were invited and consented to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | ShapeMatch Cutting Guides With Triathlon | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Implant Location/Assessment of Alignment | Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | degrees | 3 months Post-Operatively |
|
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ShapeMatch Cutting Guides With Triathlon | Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Operative site | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative site | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Fulker | Stryker SP | +61 2 9467 1072 | david.fulker@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2012 | Aug 28, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2016 | Aug 28, 2020 | ICF_001.pdf |
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|
| Pre-operative to 5 years post-operative |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 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.) | Pre-operative to 5 years post-operative |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 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.) | Pre-operative to 5 years post-operative |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 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.) | Pre-operative to 5 years Post-Operative |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 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.) | Pre-operative to 5 years post-operative |
| Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. | Pre-operative to 5 years Post-Operative |
| VAS Pain at Rest | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Pre-Operative to 5 years Post-Operative |
| VAS Pain Mobilised | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Pre-Operative to 5 years post-operative |
| Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. | Pre-operative to 5 years Post-Operative |
| Knee Society Clinical Rating System (KSS) Pain Scores | 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 minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Pre-operative to 5 years Post-Operative |
| Knee Society Clinical Rating System (KSS) Functional Scores | 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 minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Pre-operative to 5 years Post-Operative |
| Knee Society Clinical Rating System (KSS) Range of Motion Scores | 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 minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Pre-operative to 5 years Post-Operative |
| Forgotten Joint Score (FJS) | The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100. | 1 to 5 years Post-Operative |
| MRI contraindication |
|
| Consent violation |
|
| Only Recruited to Part A |
|
| Physician Decision |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | 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.) | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years post-operative |
|
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | 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.) | Participants with available data. Participants=knees | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years post-operative |
|
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | 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.) | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years post-operative |
|
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | 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.) | Participants with available data. Participants=knees | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years Post-Operative |
|
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | 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.) | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | unit of a scale | Pre-operative to 5 years post-operative |
|
|
|
|
| Secondary | Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years Post-Operative |
|
|
|
|
| Secondary | VAS Pain at Rest | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | centimeters | Pre-Operative to 5 years Post-Operative |
|
|
|
|
| Secondary | VAS Pain Mobilised | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units of a scale | Pre-Operative to 5 years post-operative |
|
|
|
|
| Secondary | Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years Post-Operative |
|
|
|
|
| Secondary | Knee Society Clinical Rating System (KSS) Pain Scores | 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 minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years Post-Operative |
|
|
|
|
| Secondary | Knee Society Clinical Rating System (KSS) Functional Scores | 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 minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years Post-Operative |
|
|
|
|
| Secondary | Knee Society Clinical Rating System (KSS) Range of Motion Scores | 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 minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative to 5 years Post-Operative |
|
|
|
|
| Secondary | Forgotten Joint Score (FJS) | The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100. | Participants with available data. Participants=knees. | Posted | Mean | Standard Deviation | units on a scale | 1 to 5 years Post-Operative |
|
|
|
|
| 1 |
| 96 |
| 48 |
| 96 |
| 47 |
| 96 |
| Non-operative site | Cardiac disorders | Non-systematic Assessment |
|
| Non-operative site | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Non-operative site | Eye disorders | Non-systematic Assessment |
|
| Non-operative site | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative site | General disorders | Non-systematic Assessment |
|
| Non-operative site | Hepatobiliary disorders | Non-systematic Assessment |
|
| Non-operative site | Infections and infestations | Non-systematic Assessment |
|
| Operative site | Infections and infestations | Non-systematic Assessment |
|
| Non-Operative site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Operative Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Non-operative site | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Non-operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Non-operative site | Psychiatric disorders | Non-systematic Assessment |
|
| Non-operative site | Renal and urinary disorders | Non-systematic Assessment |
|
| Non-operative site | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Non-operative site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-operative site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Operative site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Surgical and medical procedures | Non-systematic Assessment |
|
| Operative site | Surgical and medical procedures | Non-systematic Assessment |
|
| Non-operative side | Vascular disorders | Non-systematic Assessment |
|
| Non-operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-operative site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Discloser must give at least 40 days notice to Sponsor including a copy of the proposed publication. The Sponsor can then provide comments (which Discloser is not bound to follow), request delay of publication by no more than 120 days to allow for Sponsor to protect its intellectual property, or request that the Discloser remove certain proprietary or confidential information from the study (other than the results of the study).
|
| 3 months KOOS Pain score |
|
|
| 6 months KOOS Pain score |
|
|
| 1 year KOOS Pain score |
|
|
| 2 years KOOS Pain score |
|
|
| 5 years KOOS Pain score |
|
|
| 0.0013 |
| Superiority or Other (legacy) |
| Change from 3 months to 6 months KOOS Pain | ANOVA | 0.3316 | Superiority |
| Change from 6 months to 1 year KOOS Pain | ANOVA | 0.3366 | Superiority |
| Change from 1 year to 2 year KOOS Pain | ANOVA | 0.9826 | Superiority |
| Change from 2 year to 5 year KOOS Pain | ANOVA | 0.9276 | Superiority |
|
| 3 months KOOS Symptoms |
|
|
| 6 months KOOS Symptoms |
|
|
| 1 year KOOS Symptoms |
|
|
| 2 years KOOS Symptoms score |
|
|
| 5 years KOOS Symptoms |
|
|
| 0.0736 |
| Superiority |
| Change from 3 months to 6 months KOOS Symptoms | ANOVA | 0.4675 | Superiority |
| Change from 6 months to 1 year KOOS Symptoms | ANOVA | 0.0229 | Superiority |
| Change from 1 year to 2 year KOOS Symptoms | ANOVA | 0.9968 | Superiority |
| Change from 2 year to 5 year KOOS Symptoms | ANOVA | 0.7761 | Superiority |
|
| 3 months KOOS ADL |
|
|
| 6 months KOOS ADL |
|
|
| 1 year KOOS ADL |
|
|
| 2 years KOOS ADL score |
|
|
| 5 years KOOS ADL score |
|
|
| 0.0212 |
| Superiority |
| Change from 3 months to 6 months KOOS ADL | ANOVA | 0.7173 | Superiority |
| Change from 6 months to 1 year KOOS ADL | ANOVA | 0.1834 | Superiority |
| Change from 1 year to 2 year KOOS ADL | ANOVA | 0.9957 | Superiority |
| Change from 6 months to 1 year KOOS ADL | ANOVA | 0.9999 | Superiority |
|
| 2 years KOOS S&R |
|
|
| 5 years KOOS S&R |
|
|
| 6 weeks KOOS S&R |
|
|
| 3 months KOOS S&R |
|
|
| 6 months KOOS S&R |
|
|
| 0.0522 |
| Superiority |
| Change from 3 months to 6 months KOOS S&R | ANOVA | 0.1696 | Superiority |
| Change from 6 months to 1 year KOOS S&R | ANOVA | 0.6942 | Superiority |
| Change from 1 year to 2 year KOOS S&R | ANOVA | >0.9999 | Superiority |
| Change from 2 year to 5 year KOOS S&R | ANOVA | >0.9999 | Superiority |
|
| 3 months KOOS QOL score |
|
|
| 6 months KOOS QOL |
|
|
| 1 year KOOS QOL |
|
|
| 2 years KOOS QOL score |
|
|
| 5 years KOOS QOL |
|
|
| 0.0135 |
| Superiority |
| Change from 3 months to 6 months KOOS QoL | ANOVA | 0.0829 | Superiority |
| Change from 6 months to 1 year KOOS QoL | ANOVA | 0.1729 | Superiority |
| Change from 1 year to 2 year KOOS QoL | ANOVA | 0.9687 | Superiority |
| Change from 2 year to 5 year KOOS QoL | ANOVA | >0.9999 | Superiority |
|
| SF12 PCS 3 months |
|
|
| SF12 PCS 6 months |
|
|
| SF12 PCS 1 year |
|
|
| SF12 PCS 2 years |
|
|
| SF12 PCS 5 years |
|
|
| <0.0001 |
| Superiority |
| Change from 3 months to 6 months SF-12 PCS | ANOVA | 0.8189 | Superiority |
| Change from 6 months to 1 year SF-12 PCS | ANOVA | 0.9845 | Superiority |
| Change from 1 year to 2 year SF-12 PCS | ANOVA | 0.7500 | Superiority |
| Change from 2 year to 5 year SF-12 PCS | ANOVA | 0.1376 | Superiority |
|
| VAS pain at rest_3 months |
|
|
| VAS pain at rest_6 months |
|
|
| VAS pain at rest_ 1 year |
|
|
| VAS pain at rest_ 2 years |
|
|
| VAS pain at rest_ 5 years |
|
|
| 0.0031 |
| Superiority |
| Change from 3 months to 6 months VAS Rest | ANOVA | 0.2990 | Superiority |
| Change from 6 months to 1 year VAS Rest | ANOVA | 0.9832 | Superiority |
| Change from 1 year to 2 year VAS Rest | ANOVA | 0.9991 | Superiority |
| Change from 2 year to 5 year VAS Rest | ANOVA | >0.9999 | Superiority |
|
| VAS pain during mobilization_3 months |
|
|
| VAS pain during mobilization_6 months |
|
|
| VAS pain during mobilization_1 year |
|
|
| VAS pain during mobilization_2 years |
|
|
| VAS pain during mobilization_5 years |
|
|
| 0.0062 |
| Superiority |
| Change from 3 months to 6 months VAS Mob | ANOVA | 0.3730 | Superiority |
| Change from 6 months to 1 year VAS Mob | ANOVA | 0.8499 | Superiority |
| Change from 1 year to 2 year VAS Mob | ANOVA | >0.9999 | Superiority |
| Change from 2 year to 5 year VAS Mob | ANOVA | 0.9958 | Superiority |
|
| SF12 MCS 3 months |
|
|
| SF12 MCS 6 months |
|
|
| SF12 MCS 1 year |
|
|
| SF12 MCS 2 years |
|
|
| SF12 MCS 5 years |
|
|
| 0.4800 |
| Superiority |
| Change from 3 months to 6 months SF-12 MCS | ANOVA | >0.9999 | Superiority |
| Change from 6 months to 1 year SF-12 MCS | ANOVA | >0.9999 | Superiority |
| Change from 1 year to 2 year SF-12 MCS | ANOVA | >0.9999 | Superiority |
| Change from 2 year to 5 year SF-12 MCS | ANOVA | >0.9999 | Superiority |
|
| KSS Pain 6 months |
|
|
| KSS Pain 1 year |
|
|
| KSS Pain 2 years |
|
|
| KSS Pain 5 years |
|
|
| 0.9465 |
| Superiority |
| Change from 6 months to 1 year KSS Pain | ANOVA | 0.1215 | Superiority |
| Change from 1 year to 2 years KSS Pain | ANOVA | 0.9912 | Superiority |
| Change from 2 year to 5 year KSS Pain | ANOVA | 0.8952 | Superiority |
|
| KSS functional 6 months |
|
|
| KSS functional 1 year |
|
|
| KSS functional 2 years |
|
|
| KSS functional 5 years |
|
|
| 0.0266 |
| Superiority |
| Change from 6 months to 1 year KSS Function | ANOVA | 0.9880 | Superiority |
| Change from 1 year to 2 years KSS Function | ANOVA | 0.9699 | Superiority |
| Change from 2 year to 5 years KSS Function | ANOVA | 0.8575 | Superiority |
|
| KSS ROM 6 months |
|
|
| KSS ROM 1 year |
|
|
| KSS ROM 2 years |
|
|
| KSS ROM 5 years |
|
|
| 0.7664 |
| Superiority |
| Change from 6 months to 1 year KSS Range of Motion | ANOVA | 0.7022 | Superiority |
| Change from 1 year to 2 year KSS Range of Motion | ANOVA | >0.9999 | Superiority |
| Change from 2 year to 5 year KSS Range of Motion | ANOVA | 0.2943 | Superiority |
|
| FJS 5 years |
|
|
| <0.0001 |
| Superiority |