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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016970-33 | EudraCT Number |
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To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.
This study was an open-label, multicenter extension to the SUMMIT study designed to examine the 5-year efficacy and safety of MACI compared to arthroscopic microfracture in the treatment of articular cartilage defects of the knee in participants who received study treatment in the SUMMIT study. Follow-up to 2 years post-study treatment was completed as part of the SUMMIT study. Follow-up from 3 to 5 years post-study treatment in SUMMIT was completed in this extension study.
All 144 participants who received study treatment in the SUMMIT study were eligible for enrollment into this extension study. Participants had until the end of the visit window for the last visit of this extension study (ie, Week 260 + 6 weeks) to consent to enter this extension study.
Efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years following treatment in SUMMIT (ie, at Weeks 156, 208, and 260 postarthrotomy for patients treated with MACI implant or at Weeks 156, 208, and 260 postarthroscopy for patients treated with microfracture).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MACI | autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study |
| |
| Microfracture | Microfracture treatment received in previous MACI00206 study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous cultured chondrocytes on porcine collagen membrane | Biological | Implantation received in the previous MACI00206 study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores. | The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score. | MACI00206 Baseline to Week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores | The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score. |
Not provided
Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.
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Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urazova nemocnice v Brne | Brno | 662 50 | Czechia | |||
| University Hospital Na Bulovce- Department of Orthopaedic Surgery Postgraduate Medical Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | MACI | autologous cultured chondrocytes on porcine collagen membrane: Implantation |
| FG001 | Microfracture | Microfracture: Arthroscopic Microfracture |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Microfracture | Procedure | Arthroscopic Microfracture treatment received in the previous MACI00206 study |
|
| MACI00206 Baseline and Week 260 |
| Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill | MRI was assessed by the independent blinded evaluators by means of consensus. The number of participants with a degree of defect fill of >50% is reported. | Week 260 |
| Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores | A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline scores. | Up to week 260 |
| The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures | Patients were considered as a treatment failure if all of the following 5 criteria were met:
| Years 2 through 5 post treatment (MACI or microfracture) |
| Average Time to Treatment Failure | ANALYSIS NOT DONE: The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. The number of per protocol treatment failures in each treatment group are reported here. Patients were considered as a treatment failure if all of the following 5 criteria were met:
| Up to 260 weeks |
| Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS | The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score. | MACI00206 Baseline and Week 260 |
| Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form | The IKDC Subjective Knee Evaluation Form is a validated knee-specific measure of symptoms, function, and sports activity that is appropriate for patients with a wide variety of knee problems. The form consists of 18 items covering the domains of symptoms, functioning during activities of daily living and sports, and current function of the knee. The IKDC Subjective Knee Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100. The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms. | MACI00206 Baseline and Week 260 |
| Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System | The Modified Cincinnati Knee Rating System is a self-assessment of the intensity of sports participation, functional limitations, and the ability to participate in different types of sports. The Modified Cincinnati Knee Rating System overall knee condition score ranges from 1 (poor) to 10 (excellent). | MACI00206 Baseline and Week 260 |
| Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores | The SF-12 is a subset of the 36-Item Short-Form Health Survey (SF-36) and includes 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are used to calculate the physical (PCS) and mental (MCS) summary component scores. MCS and PCS are summarized as Z-scores using standard SF-12 scoring and a US population means. The Z-score indicates how many standard deviations a score is from the population mean. Higher values reflect better health. Changes from Baseline are reported. | MACI00206 Baseline and Week 260 |
| Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score | The EQ-5D is a standardized instrument for use as a measure of health outcome (see the EuroQOL Website for details: www.euroqol.org). Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ Visual Analogue Scale (VAS) was used to record the respondents' self-rated health status on a vertical graduated (0-100) VAS where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'. | MACI00206 Baseline and Week 260 |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) | Years 2 through 5 post treatment (MACI or microfracture) |
| Number of Participants Reporting Serious Adverse Events (SAEs) | Years 2 through 5 post treatment (MACI or microfracture) |
| Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee | Years 2 through 5 post treatment (MACI or microfracture) |
| Prague |
| 180 81 |
| Czechia |
| Polyclinique Saint-Roch | Montpellier | 34967 | France |
| Clinique Maussins-Nollet | Paris | 75019 | France |
| Hôpital d'instruction des Armées Robert Picqué | Villenave-d'Ornon | 33882 | France |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| St. Elisabeth Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| University Medical Centre of Utrecht, Department of Orthopaedics | Utrecht | 3508 GA | Netherlands |
| St Olavs Hospital | Trondheim | 7006 | Norway |
| Orthopaedic & Traumatology of Motor Organs, Independent Public Clinic Hospital | Bydgoszcz | 85-094 | Poland |
| Regional Centre of Knee Surgery & Arthroscopy, Regional Hospital of Traumatologic Surgery | Piekary ÅšlÄ…skie | 41-940 | Poland |
| Lekmed Medical Center | Warszewo | 01-480 | Poland |
| Kungsbacka Närsjukhus | Kungsbacka | 434 80 | Sweden |
| University of Oxford, Nuffield Dept. of Orthopaedic Surgery | Oxford | OX3 7LD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
The patients who did not elect to participate in the Extension study differed in their degree of response in SUMMIT relative to those who elected to participate in the Extension (ie, loss of higher-responding MACI patients and lower-responding microfracture patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | MACI | autologous cultured chondrocytes on porcine collagen membrane: Implantation |
| BG001 | Microfracture | Microfracture: Arthroscopic Microfracture |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of MACI or microfracture treatment | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores. | The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score. | The analysis population (n=128) consists of a subpopulation of participants enrolled in the SUMMIT study (n=144). 65 of 65 MACI treated patients and 57 of 63 microfracture-treated patients completed the KOOS at Week 156. | Posted | Mean | Full Range | units on a scale | MACI00206 Baseline to Week 156 |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores | The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score. | Analysis population includes all participants who completed each KOOS subscale at Week 260. | Posted | Mean | Full Range | units on a scale | MACI00206 Baseline and Week 260 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill | MRI was assessed by the independent blinded evaluators by means of consensus. The number of participants with a degree of defect fill of >50% is reported. | all participants with an MRI at Week 260 | Posted | Count of Participants | Participants | Week 260 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores | A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline scores. | Posted | Count of Participants | Participants | Up to week 260 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures | Patients were considered as a treatment failure if all of the following 5 criteria were met:
| Posted | Count of Participants | Participants | Years 2 through 5 post treatment (MACI or microfracture) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Average Time to Treatment Failure | ANALYSIS NOT DONE: The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. The number of per protocol treatment failures in each treatment group are reported here. Patients were considered as a treatment failure if all of the following 5 criteria were met:
| Posted | Count of Participants | Participants | Up to 260 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS | The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score. | Analysis population includes all participants who completed each KOOS subscale at Week 260. | Posted | Mean | Full Range | units on a scale | MACI00206 Baseline and Week 260 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form | The IKDC Subjective Knee Evaluation Form is a validated knee-specific measure of symptoms, function, and sports activity that is appropriate for patients with a wide variety of knee problems. The form consists of 18 items covering the domains of symptoms, functioning during activities of daily living and sports, and current function of the knee. The IKDC Subjective Knee Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100. The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms. | 64 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the IKDC form at Week 260. | Posted | Mean | Full Range | units on a scale | MACI00206 Baseline and Week 260 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System | The Modified Cincinnati Knee Rating System is a self-assessment of the intensity of sports participation, functional limitations, and the ability to participate in different types of sports. The Modified Cincinnati Knee Rating System overall knee condition score ranges from 1 (poor) to 10 (excellent). | 65 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the Modified Cincinnati Knee Rating System at Week 260. | Posted | Mean | Full Range | units on a scale | MACI00206 Baseline and Week 260 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores | The SF-12 is a subset of the 36-Item Short-Form Health Survey (SF-36) and includes 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are used to calculate the physical (PCS) and mental (MCS) summary component scores. MCS and PCS are summarized as Z-scores using standard SF-12 scoring and a US population means. The Z-score indicates how many standard deviations a score is from the population mean. Higher values reflect better health. Changes from Baseline are reported. | 65 of the 65 MACI-treated patients and 55 of the 63 microfracture-treated patients enrolled in MACI00809 completed the 12-Item Short-Form Health Survey at Week 260. | Posted | Mean | Full Range | Z-score | MACI00206 Baseline and Week 260 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score | The EQ-5D is a standardized instrument for use as a measure of health outcome (see the EuroQOL Website for details: www.euroqol.org). Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ Visual Analogue Scale (VAS) was used to record the respondents' self-rated health status on a vertical graduated (0-100) VAS where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'. | 65 of the 65 MACI-treated patients and 58 of the 63 microfracture-treated patients enrolled in MACI00809 completed the EQ-5D VAS Score at Week 260. | Posted | Mean | Full Range | units on a scale | MACI00206 Baseline and Week 260 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) | Posted | Count of Participants | Participants | Years 2 through 5 post treatment (MACI or microfracture) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) | Posted | Count of Participants | Participants | Years 2 through 5 post treatment (MACI or microfracture) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee | Posted | Count of Participants | Participants | Years 2 through 5 post treatment (MACI or microfracture) |
|
|
Years 2 through 5 post treatment (MACI or microfracture)
Not provided
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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 | MACI | autologous cultured chondrocytes on porcine collagen membrane: Implantation | 16 | 65 | 49 | 65 | ||
| EG001 | Microfracture | Microfracture: Arthroscopic Microfracture | 17 | 63 | 46 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cartilage Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Treatment Failure | General disorders | MedDRA (18.0) | Systematic Assessment | Adverse events of treatment failure were reported by the Investigator. Not all adverse events of treatment failure met the protocol-specified definition of treatment failure. |
|
| Graft delamination | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment | The event of graft delamination was also reported as a treatment failure. |
|
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatic injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ligament laxity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Otosclerosis | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cartilage Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
Potential problems that may be observed with elective participation in extension studies were observed in the SUMMIT Extension. Thus, the value of inferential testing that compares treatment groups without accounting for missing data is limited.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Remmers, Senior Director, Clinical Science | Vericel Corporation | 734-428-4526 | aremmers@vcel.com |
| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
Not provided
Not provided
| Male |
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| Netherlands |
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| Sweden |
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| Norway |
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| Poland |
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| United Kingdom |
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| France |
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