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This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETN PROtect | There is only 1 cohort in this case series |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETN PROtect | Device | Expert Tibial Nail PROtect with Gentamicin coating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: SF-12 Physical Component Summary (PCS) | The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively. | 3, 6, 12 and 18 months post-operatively |
| Quality of Life: SF-12 Mental Component Summary (MCS) | The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively. | 3, 6, 12 and 18 months post-operatively |
| Quality of Life: EQ-5D | The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life. | 3, 6, 12 and 18 months post-operatively |
| Functional Outcome: IOWA Ankle Score | The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Anatomic Bone Union According to Johnson Classification | Anatomic bone union was assessed according to Johnson et al.*: A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site. *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting to the ER with a tibia fracture
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Raschke, MD | University Hospital of Münster, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany | |||
| Universitätsklinikum Freiburg |
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| ID | Title | Description |
|---|---|---|
| FG000 | ETN PROtect | ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population consistes of patients with an open or closed tibia fracture who were treated with the ETN PROtect.
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| ID | Title | Description |
|---|---|---|
| BG000 | ETN PROtect | There is only 1 cohort in this case series. ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating |
| 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 | Quality of Life: SF-12 Physical Component Summary (PCS) | The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 3, 6, 12 and 18 months post-operatively |
|
Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
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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 | ETN PROtect | ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BACK PAIN AGGRAVATED | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALLERGIC REACTION | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Synthes GmbH | 0041 32 720 44 65 | clinicalaffairs.emea@synthes.com |
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| Baseline, 3, 6, 12 and 18 months post-operatively |
| Functional Outcome: WOMAC | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee. Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations. | 3, 6, 12 and 18 months post-operatively |
| Infection Adverse Events | Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:
| 0 - 18 months |
| 12 months |
| Evidence of Economic Bone Union According to Johnson Classification | Economic bone union was assessed according to Johnson et al.*: E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions. *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 | 12 months |
| Evidence of Functional Bone Union According to Johnson Classification | Functional bone union was assessed according to Johnson et al.*: F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity. *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 | 12 months |
| Surgeon's Perceived Satisfaction | Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed). | 6 weeks, 3 and 6 months post-operatively |
| Likelihood to Develop Wound Infection Assessed by Surgeon | The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure). | 6 weeks, 3 and 6 months post-operatively |
| Likelihood to Develop a Non-union Assessed by Surgeon | The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure). | 6 weeks, 3 and 6 months post-operatively |
| Pain by Visual Analog Scale (VAS) | Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain. | 6 weeks, 3, 6, 12 and 18 months post-operatively |
| Patient's Perceived Satisfaction | Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied. | 6 months |
| Time to Full Weight Bearing | The time from surgery to full weight bearing was assessed in days. | 0 - 18 months |
| Freiburg im Breisgau |
| 79106 |
| Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| University Hospital of Münster | Münster | 48149 | Germany |
| Patient non-compliance |
|
| Physician Decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Allergies | Number | participants |
|
| Smoking | Number | participants |
|
| Drinking | Number | participants |
|
| Drugs | Number | participants |
|
| Fracture type | Patients were divided into two groups of fracture types: (1) traumatic/pathologic fractures and (2) other: patients receiving the ETN PROtect due to revision purposes. | Number | participants |
|
| Fracture type (open or closed) | Number | participants |
|
| Time from injury to surgery for traumatic/pathologic patients | The time-to-surgery was recorded for 67 traumatic/pathologic patients. | Mean | Standard Deviation | days |
|
| Time from injury to surgery for revision patients | The time-to-surgery was recorded for 21 revision-patients. | Mean | Standard Deviation | months |
|
| Use of systemic antibiotics prophylaxis | More than one option possible. | Number | participants |
|
| OG000 |
| ETN PROtect |
ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating. |
|
|
| Primary | Quality of Life: SF-12 Mental Component Summary (MCS) | The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 3, 6, 12 and 18 months post-operatively |
|
|
|
| Primary | Quality of Life: EQ-5D | The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 3, 6, 12 and 18 months post-operatively |
|
|
|
| Secondary | Evidence of Anatomic Bone Union According to Johnson Classification | Anatomic bone union was assessed according to Johnson et al.*: A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site. *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). For the anatomic bone union at 12 months, data of 78 patients is available. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Evidence of Economic Bone Union According to Johnson Classification | Economic bone union was assessed according to Johnson et al.*: E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions. *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). For the anatomic bone union at 12 months, data of 78 patients is available. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Evidence of Functional Bone Union According to Johnson Classification | Functional bone union was assessed according to Johnson et al.*: F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity. *Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). For the anatomic bone union at 12 months, data of 78 patients is available. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Surgeon's Perceived Satisfaction | Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed). | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 6 weeks, 3 and 6 months post-operatively |
|
|
|
| Primary | Functional Outcome: IOWA Ankle Score | The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 3, 6, 12 and 18 months post-operatively |
|
|
|
| Primary | Functional Outcome: WOMAC | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee. Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 3, 6, 12 and 18 months post-operatively |
|
|
|
| Primary | Infection Adverse Events | Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:
| Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Number | number of events | 0 - 18 months |
|
|
|
| Secondary | Likelihood to Develop Wound Infection Assessed by Surgeon | The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure). | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 6 weeks, 3 and 6 months post-operatively |
|
|
|
| Secondary | Likelihood to Develop a Non-union Assessed by Surgeon | The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure). | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 6 weeks, 3 and 6 months post-operatively |
|
|
|
| Secondary | Pain by Visual Analog Scale (VAS) | Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). | Posted | Mean | Standard Deviation | scores on a scale | 6 weeks, 3, 6, 12 and 18 months post-operatively |
|
|
|
| Secondary | Patient's Perceived Satisfaction | Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). Patient satisfaction was completed by 84 patients. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| Secondary | Time to Full Weight Bearing | The time from surgery to full weight bearing was assessed in days. | Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). 3 patients never reached full weight bearing, and 1 dropped out before 6 weeks. | Posted | Median | Full Range | days | 0 - 18 months |
|
|
|
| 38 |
| 99 |
| 49 |
| 99 |
| COXARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEVICE BREAKAGE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| DISORDERS OF MUSCLE, LIGAMENT, AND FASCIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| ECTOPIC OSSIFICATION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| FRACTURE DELAYED UNION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| FRACTURE MALUNION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| FRACTURE NONUNION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| HAMMER TOE | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEART ATTACK | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEMATOMA | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| LOCAL SWELLING | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| LOCALIZED INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| LOSS OF RANGE OF MOTION ASSOCIATED WITH DEVICE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| MEDICAL DEVICE COMPLICATION | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| NONUNION OF FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PAIN IN FOOT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| POST-OPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PSEUDARTHROSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PSYCHOSIS | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| SKIN NECROSIS | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| SOFT TISSUE NECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| SURGICAL WOUND INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SWELLING | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| THROMBOSIS LEG | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| WOUND HEALING DISTURBANCE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| BONE FRACTURE SPONTANEOUS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| BONE FRAGILE | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| BONE FRAGMENTATION | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| BRUISE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| CALF PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHONDROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| COXARTHROSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| COXITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEPRESSION WORSENED( | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEPRESSIVE EPISODE | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEVICE POSITIONED INAPPROPRIATELY | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| DUODENITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| FRACTURE DELAYED UNION | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| HALLUX VALGUS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEALING DELAYED | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEMATOMA | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| IMPINGEMENT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| KNEE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| LOCAL SWELLING | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| LYMPHEDEMA | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| NEUROPATHY | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| NON-INSULIN-DEPENDENT DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| NONUNION OF FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| NUMBNESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| NUMBNESS IN LEG | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| OPERATION SITE BLEED | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| PAIN IN FOOT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PARASTHESIA | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| PATELLAR TENDINITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| POLYNEUROPATHY | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| PROLONGED POSTTRAUMATIC STRESS DISORDER | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| SKIN LESION NOS | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| SKIN NECROSIS( | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| STRESS FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| SUBLUXATION PATELLA | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| SURGICAL WOUND INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| SUTURE GRANULOMA | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| SWELLING | General disorders | MedDRA 15.0 | Systematic Assessment |
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| SWELLING OF LEGS | General disorders | MedDRA 15.0 | Systematic Assessment |
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| TIBIA PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| UNEQUAL LEG LENGTH (ACQUIRED) | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| URINARY TRACT DISORDER | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| WHITLOW | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| WOUND HEALING DISTURBANCE | General disorders | MedDRA 15.0 | Systematic Assessment |
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A single comprehensive publication may be authored on the procedure and outcomes of the trial. Sites that enroll less than five patients will not be included in the publication. Synthes GmbH will have the right to review prior to submission.
Each clinical site that enrolls ten patients will have the option to submit an abstract for publication or presentation at a regional, national, or international conference on their work. Synthes GmbH will have the right to review prior to submission.
| Title | Measurements |
|---|---|
|
| Score at 18 months, n=68 |
|
| Title | Measurements |
|---|---|
|
| Score at 18 months, n=72 |
|
| Title | Measurements |
|---|
|
| A3 |
|
| A4 |
|
| Title | Measurements |
|---|
|
| E3 |
|
| E4 |
|
| Title | Measurements |
|---|
|
| F3 |
|
| F4 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Score at 12 months, n=77 |
|
| Score at 18 months, n=73 |
|
| Title | Measurements |
|---|---|
|
| Score at 18 months, n=73 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Score at 12 months, n=78 |
|
| Score at 18 months, n=73 |
|