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| Name | Class |
|---|---|
| Biomet Belgium BVBA | INDUSTRY |
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This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.
The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis will be used.
The secondary objectives are:
Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.
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| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured. | Pre-operative, 1, 3 and 5 years follow-up |
| Key Pinch Strength | Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured. | Pre-operative, 1, 3 and 5 years follow-up |
| Tip Pinch Strength | Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured. | Pre-operative, 1, 3 and 5 years follow-up |
| VAS Pain | Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain). | Pre-operative, 1, 3 and 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Motion - ROM Measurement - Radial Abduction | The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. ROM in radial abduction is measured while the patients move the thumb in parallel to the palm. | Pre-operative, 1, 3 and 5 years follow-up |
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Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.
Inclusion Criteria:
Exclusion Criteria:
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Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.
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| Name | Affiliation | Role |
|---|---|---|
| Frederik VERSTREKEN, PhD | SPM Deurne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPM Deurne | Deurne | 2100 | Belgium |
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According to the protocol, 100 subjects were to be enrolled. Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARPE Prosthesis | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-operative |
| |||||||||||||
| 1 Year Follow-up |
| |||||||||||||
| 3 Year Follow-up |
| |||||||||||||
| 5 Year Follow-up |
|
Number of Unilateral Patients: 90; Number of Bilateral Patients: 5.
| ID | Title | Description |
|---|---|---|
| BG000 | ARPE Prosthesis | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| 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 | Grip Strength | Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | kg | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
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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 | ARPE Prosthesis | Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prosthesis luxation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device-related SAE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thumb pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilie Rohmer, Clinical Operations Manager | Zimmer Biomet | +41 58 85 48210 | Emilie.Rohmer@zimmerbiomet.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 | Nov 12, 2012 | Sep 21, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Motion - ROM Measurement - Palmar Abduction |
The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. The ROM in palmar abduction is measured while the patients move the thumb perpendicularly to the palm. |
| Pre-operative, 1, 3 and 5 years follow-up |
| EQ-5D - Health Status Score | EQ-5D is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. | Pre-operative, 1, 3 and 5 years follow-up |
| EQ-5D - VAS Score | The second part of the EQ-5D questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). | Pre-operative, 1, 3 and 5 years follow-up |
| Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis | Radiolucency lines are radiolucent gaps visible in the radiographic images between the prosthesis and the bone, which presence is commonly associated with early failure of the implantation, eventually leading to the loosening of the prosthesis. Every radiography taken at each follow-up time point was assessed to evaluate whether there are visible radiolucency lines around the implanted prosthesis and the number of implants with visible radiolucency lines is here reported. | 1, 3 and 5 years follow-up |
| Hand Function: DASH Questionnaire - Disability | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. | Pre-operative, 1, 3 and 5 years follow-up |
| Hand Function: DASH Questionnaire - Work | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. | Pre-operative, 1, 3 and 5 years follow-up |
| Hand Function: DASH Questionnaire - Sport | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. | Pre-operative, 1, 3 and 5 years follow-up |
|
|
|
| implants |
|
| years |
| implants |
|
|
| Sex: Female, Male | Count of Units | implants | implants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Surgery Side Distribution | Count of Units | implants | implants |
|
|
| Weight Distribution | Mean | Standard Deviation | kg | implants |
|
|
| Height Distribution | Mean | Standard Deviation | cm | implants |
|
|
| Other Joint Involvement of the Hand | Count of Units | implants | implants |
|
|
| Previous Hand Surgeries/Treatments on Affected Hand | Count of Units | implants | implants |
|
|
| Trapezio Metacarpal Arthritis Disease Stage | The Eaton radiographic classification system categorizes trapezio-metacarpal arthritis in 4 stages, with stage I being the better outcome and stage IV being the worst outcome. Stage I: slight joint space widening, normal articular contours; Stage II: Slight narrowing of joint space with osteophytes; Stage III: Marked narrowing of joint space with osteophytes, cystic changes, sclerotic bone; Stage IV: Complete deterioration of the joint, scaphotrapezial joint narrowed with sclerotic and cystic changes apparent. Only patients with Eaton Stages II to IV were included in this study. | Count of Units | implants | implants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| implants |
|
|
| Primary | Key Pinch Strength | Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | kg | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Primary | Tip Pinch Strength | Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | kg | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Primary | VAS Pain | Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain). | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | Motion - ROM Measurement - Radial Abduction | The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. ROM in radial abduction is measured while the patients move the thumb in parallel to the palm. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | degrees | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | Motion - ROM Measurement - Palmar Abduction | The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. The ROM in palmar abduction is measured while the patients move the thumb perpendicularly to the palm. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | degrees | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | EQ-5D - Health Status Score | EQ-5D is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | EQ-5D - VAS Score | The second part of the EQ-5D questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis | Radiolucency lines are radiolucent gaps visible in the radiographic images between the prosthesis and the bone, which presence is commonly associated with early failure of the implantation, eventually leading to the loosening of the prosthesis. Every radiography taken at each follow-up time point was assessed to evaluate whether there are visible radiolucency lines around the implanted prosthesis and the number of implants with visible radiolucency lines is here reported. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. There were no radiolucency lines reported for any of the patients included in the study at any time point. | Posted | Count of Units | implants | 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | Hand Function: DASH Questionnaire - Disability | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | Hand Function: DASH Questionnaire - Work | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. The Work category is optional. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| Secondary | Hand Function: DASH Questionnaire - Sport | The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional. The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability. | Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. The Sports category is optional. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 1, 3 and 5 years follow-up | implants | implants |
|
|
|
| 0 |
| 95 |
| 17 |
| 95 |
| 19 |
| 95 |
|
| Hip replacement | Surgical and medical procedures | Systematic Assessment | Resolved with surgery |
|
| Anaphylactic shock | General disorders | Systematic Assessment | To unknown medication, resolved with hospitalization |
|
| Discectomy | Surgical and medical procedures | Systematic Assessment |
|
| Malnutrition | General disorders | Systematic Assessment | Resolved with hospitalization and diet |
|
| Heart arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Gonarthrosis | Surgical and medical procedures | Systematic Assessment | Resolved with surgery |
|
| Neck problems | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Prostate hypertrophy | Reproductive system and breast disorders | Systematic Assessment | Resolved with surgery |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Resolved with surgery |
|
| Bladder prolapse | Renal and urinary disorders | Systematic Assessment | Resolved with surgery |
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| Gastric bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Rizarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | In contralateral thumb, resolved with surgery |
|
| Cuff tear shoulder | Surgical and medical procedures | Systematic Assessment | Resolved with surgery |
|
| Fracture of pseudoarthrosis radius | Surgical and medical procedures | Systematic Assessment | Resolved with surgery |
|
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | De Quervain tenosynovitis |
|
| Thumb and/or wrist pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Caused by overload; device-related therefore reported even if <1% frequency |
|
| Carpal tunnel | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Thumb infection | Infections and infestations | Systematic Assessment |
|
| Arthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | STT arthrosis and arthrosis in midcarpal and radiocarpal; device-related therefore reported even if <1% frequency |
|
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| 1 year follow-up |
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| 3 years follow-up |
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| 5 years follow-up |
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| 5 years follow-up |
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| 5 years follow-up |
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| 1 year follow-up |
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| 5 years follow-up |
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| 1 year follow-up |
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| 1 year follow-up |
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| 1 year follow-up |
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| 5 year follow-up |
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| 1 year follow-up |
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| 1 year follow-up |
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