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The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.
The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates.
One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received DVR Plating System |
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| Measure | Description | Time Frame |
|---|---|---|
| Fracture Healing Based on Clinical Measures and X-rays | Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site) | Mean time of 3.8 years after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Product Safety Based on Complications | Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs). . | Mean time of 3.8 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must have received one of the DVR Plates and who meet all of the inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton General Hospital | Southampton | United Kingdom |
191 consecutive patients were identified at the Southampton General Hospital. 11 patients died or moved out of the area so they could not be enrolled. So 180 patients were contacted and were asked to consider their study participation. 69 patients were either not reachable within three attempts or declined study participation leaving us with 111 patients enrolled into this study.
Southampton General Hospital
| ID | Title | Description |
|---|---|---|
| FG000 | DVR Plating System | Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Last Consultation Visit at the Hospital |
| |||||||||||||
| Follow-up Phone Call |
|
This is a retrospective study meaning that retrospective data from preoperative, operative, immediate postoperative and last consultation visit was collected from patients' charts that have been operated in the past. Due to this retrospective design of the study the retrieval of demographic information from past medical records was not always possible as some medical records did not contain all information.
| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Received DVR Plating System | Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years |
| 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 | Fracture Healing Based on Clinical Measures and X-rays | Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site) | Posted | Count of Units | cases | Mean time of 3.8 years after the surgery | cases | cases |
|
|
Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 | 111 Subjects Received DVR Plating System With a Mean Follow-up of 3.8 Years | Single study patient cohort, including 111 participants (115 patients) who meet the inclusion/exclusion criteria and who received the DVR Plating System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered sensation of the median nerve | Nervous system disorders | Systematic Assessment | Altered sensation of the median nerve |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain due to altered sensation | Nervous system disorders | Systematic Assessment | Patient experiences shooting pains in hand. Surgery wasn't offered as wasn't thought to improve outcome. Subject is seeing independent specialist and was discharged from clinic. |
The limitations of this study are that it was retrospective, over the pandemic and required extensive hours of discussion and contacting of patients which took extended time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georgia Tsapara | Zimmer Biomet | +41 79 94 54936 | georgia.tsapara@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 | May 8, 2019 | Dec 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Patient's Outcomes Were Also Assessed | Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)* and a question on their wrist function** * the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability ** Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury. | Mean time of 3.8 years after surgery |
| cases |
|
| Standard Deviation |
| years |
| cases |
|
|
| Sex: Female, Male | Count of Units | cases | cases |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Units | cases | cases |
|
|
| Weight, Continuous | As the retrieval of the demographic data was not always possible the number of cases for the weight differs from the total amount of cases. | Mean | Standard Deviation | Kg | cases |
|
|
| Height, Continuous | As the retrieval of the demographic data was not always possible the number of cases for the height differs from the total amount of cases. | Mean | Standard Deviation | cm | cases |
|
|
| Body Mass Index, Continuous | As the retrieval of the demographic data was not always possible the number of cases for the body mass index differs from the total amount of cases. | Mean | Standard Deviation | Kg/m^2 | cases |
|
|
| cases |
|
|
| Secondary | Product Safety Based on Complications | Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs). . | complications [Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs)] that occurred in the study cohort during the time of the study | Posted | Count of Units | complications classified per ISO14155 | Mean time of 3.8 years after surgery | complications classified per ISO14155 | complications classified per ISO14155 |
|
|
|
| Secondary | Patient's Outcomes Were Also Assessed | Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)* and a question on their wrist function** * the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability ** Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury. | In a case the General Wrist Function could not be assessed as the patient is suffering from Kienbock's disease and is experiencing a lot of pain, therefore the General Wrist Function is calculated for 113 cases. | Posted | Mean | Standard Deviation | cases | Mean time of 3.8 years after surgery | cases | cases |
|
|
|
| 0 |
| 111 |
| 4 |
| 111 |
| 59 |
| 111 |
|
| Car accident | Injury, poisoning and procedural complications | Systematic Assessment | Fracture of ribs and hip due to a car accident |
|
| Reduced mobility | Musculoskeletal and connective tissue disorders | Systematic Assessment | Reduced mobility, as patient unable to use the left thumb which heavily impacts the ability to perform any task with left hand - patient reported this was due to a ruptured tendon as a result of plaster cast |
|
| Kienbock's disease | Vascular disorders | Systematic Assessment | Patient is experiencing ongoing significant pain due to Kienbock's disease |
|
|
| Plate removal | Nervous system disorders | Systematic Assessment | Patient had wrist plate removed due to "rubbing against nerve-screw was pressing against skin". Patient pointed out a small lump on the radial border of wrist which is quite tender and possibilities this may be a screw. |
|
| Shoulder/ arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient received epidural injection for trapped nerve/shoulder/arm pain |
|
| Pain in wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Loose screw | Product Issues | Systematic Assessment | Patient said a screw was "loose" according to the x-rays during clinic appointment - has not caused any issues |
|
| Stiffness and pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Shooting spasm pains | Musculoskeletal and connective tissue disorders | Systematic Assessment | Experiences shooting spasm pains down arm and wrist - especially when using wrist a lot during working. Pain is not bad enough to stop subject from doing anything. 2- Patient experiences very occasional sudden shooting pain - no clear cause |
|
| Rotator cuff impingement | Nervous system disorders | Systematic Assessment | Rotator cuff impingement with long head of biceps medialisation. Severe stiffness due to multiple injuries and prolonged reduced mobilization. |
|
| Collapsed joint line | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Mild ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Intermittent pain and instability | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experiences intermittent pain in wrist and mentioned experiencing ongoing instability and it has some deformity -There was pre-existing instability of the DRUJ therefore the complication is unrelated to the device. |
|
| Lower Respiratory Tract Infection (LRTI) | Infections and infestations | Systematic Assessment | Patient developed a LRTI post op and was given a course of antibiotics - extended hospital stay |
|
| Arthritis | Immune system disorders | Systematic Assessment |
|
|
| Low wrist function | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient attributed lower rated wrist function due to "stiff fingers"- unable to make a fist with left hand |
|
| Additional fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
|
| Discomfort and pain | Product Issues | Systematic Assessment | 1- Patient experienced discomfort and pain following operation. Shooting pain into ring and little finger, reduced grip and trouble rotating wrist |
|
| Polytrauma | Injury, poisoning and procedural complications | Systematic Assessment | Polytrauma - long hospital stay |
|
| Aching and pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject experiences aching and some pain depending on the weather - affects subject intermittently |
|
| Plate removal | Product Issues | Systematic Assessment |
|
|
| Long recovery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Recovery after surgery took longer than the time frame the surgeon gave. Patient struggled to move fingers and wrist significantly post-surgery |
|
| Complex Regional Pain Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experiences significant pain when lifting any heavy object and has ongoing weakness in affected hand/wrist |
|
| Pain in wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Reduced ROM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Pain when lifting heavy objects | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient struggles with pain when lifting heavy objects (more than 5kg) and with repeated movements like using a tin opener or using bathroom tissue. Patient avoids these activities. |
|
| Occasional pain and slightly reduced ROM | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient since operation gets occasional pain and slight reduced ROM, only at it's worse during cold weather. The pain rarely affects the patient. |
|
| Numbness | Nervous system disorders | Systematic Assessment | Patient experiences numbness in thumb, index & middle fingers which is related to the nerve dysfunction |
|
| Swollen wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment | Swollen wrist with a globally reduced range of motion which results to the hand movement stiffness |
|
| Polymyalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain post operatively leading to prolonged stay. Background of Polymyalgia which can often predispose to pain control issues. Difficult to say if pain from swelling of original fracture of from procedure. |
|
| Shooting nerve pain in wrist | Nervous system disorders | Systematic Assessment | Patient experiences shooting/nerve pain in wrist when completing certain tasks like using a bathroom tissue. Does not occur often but can be really painful |
|
| Stitches opened | Skin and subcutaneous tissue disorders | Systematic Assessment | Patient's stitches/wound opened up the day after surgery - bleeding inside the cast. Went t back to hospital to have her wound re-dressed and re-cast. |
|
| Bones moving forward | Injury, poisoning and procedural complications | Systematic Assessment | Plate has not stopped the bones from moving forward |
|
| Tingling sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
|
| Clicking and minor weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experiences clicking in wrist when moving and some minor weakness when lifting heavy objects |
|
| Thicker wrist | Product Issues | Systematic Assessment | Patient's operated wrist is thicker than other (non-operated) wrist |
|
| Plate pincing nerve | Product Issues | Systematic Assessment | Patient is complaining of the plate pinching a nerve in wrist causing issues with thumb (stiffness and poor flexibility) |
|
| Loss of power and grip strenght | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Concurring spinal injuries | Injury, poisoning and procedural complications | Systematic Assessment | Patient had delayed discharge due to concurring spinal injuries |
|
| Collapse at fracture site | Product Issues | Systematic Assessment | Collapse at fracture site resulting in metalwork removal (plate and screws) |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Back pain/nerve pain in back that sometimes affects both arms |
|
| Stiffness and irritation caused by the plate | Product Issues | Systematic Assessment |
|
|
| Dull ache | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experiences dull ache in wrist, this pain can prevents patient from doing push-ups and from writing for extended periods of time |
|
| Wrist weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experiences some wrist weakness |
|
| Enlarged scar | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pins and needles feeling | Nervous system disorders | Systematic Assessment |
|
|
| Pain combined with stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Pain when performing repeated wrist movements | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Reduced strength | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
|
| Inpatient fall | Injury, poisoning and procedural complications | Systematic Assessment | Inpatient fall sustaining skull fracture with concurrent subdural hematoma - longer admission |
|
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| Title | Measurements |
|---|---|
|
| Serious Adverse Device Effects (SADEs) |
|
| General Wrist Function |
|
|