Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
Conditions
Keywords
Medical Device, Performance, Safety, Clinical Benefits, Post-Market Clinical Follow-Up Study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All subjects must have been implanted with one of the DVR Plates according to the approved indications.
Exclusion criteria
* Off-label use. * Cases where there is an active infection. * Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc. * Insufficient quantity or quality of bone to permit stabilization of the fracture. * Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process. * Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations. * Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients. * Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fracture Healing Based on Clinical Measures and X-rays | Mean time of 3.8 years after the surgery | Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product Safety Based on Complications | Mean time of 3.8 years after surgery | 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). . |
| Patient's Outcomes Were Also Assessed | Mean time of 3.8 years after surgery | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Southampton General Hospital
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 111 |
| 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 | 115 |
| Total | 226 |
Baseline characteristics
| Characteristic | Subjects Received DVR Plating System |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 18.5 |
| Body Mass Index, Continuous | 26.3 Kg/m^2 STANDARD_DEVIATION 5.7 |
| Height, Continuous | 165.8 cm STANDARD_DEVIATION 16.2 |
| Region of Enrollment United Kingdom | 115 cases |
| Sex: Female, Male Female | 76 cases |
| Sex: Female, Male Male | 39 cases |
| Weight, Continuous | 73.8 Kg STANDARD_DEVIATION 17.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 111 |
| other Total, other adverse events | 59 / 111 |
| serious Total, serious adverse events | 4 / 111 |
Outcome results
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)
Time frame: Mean time of 3.8 years after the surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| DVR Plating System | Fracture Healing Based on Clinical Measures and X-rays | X-ray Evaluation | Fracture/Osteotomy healing not assessed | 10 cases |
| DVR Plating System | Fracture Healing Based on Clinical Measures and X-rays | X-ray Evaluation | Fracture/Osteotomy healed | 103 cases |
| DVR Plating System | Fracture Healing Based on Clinical Measures and X-rays | X-ray Evaluation | Fracture/Osteotomy not healed | 2 cases |
| DVR Plating System | Fracture Healing Based on Clinical Measures and X-rays | Clinical Evaluation | Fracture/Osteotomy healed | 114 cases |
| DVR Plating System | Fracture Healing Based on Clinical Measures and X-rays | Clinical Evaluation | Fracture/Osteotomy not healed | 0 cases |
| DVR Plating System | Fracture Healing Based on Clinical Measures and X-rays | Clinical Evaluation | Fracture/Osteotomy healing not assessed | 1 cases |
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.
Time frame: Mean time of 3.8 years after surgery
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DVR Plating System | Patient's Outcomes Were Also Assessed | PRWE Score | 12.8 cases | Standard Deviation 17.9 |
| DVR Plating System | Patient's Outcomes Were Also Assessed | General Wrist Function | 8.0 cases | Standard Deviation 2.1 |
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). .
Time frame: Mean time of 3.8 years after surgery
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| DVR Plating System | Product Safety Based on Complications | Serious Adverse Device Effects (SADEs) | 0 complications classified per ISO14155 |
| DVR Plating System | Product Safety Based on Complications | Adverse Events (AEs) | 77 complications classified per ISO14155 |
| DVR Plating System | Product Safety Based on Complications | Serious Adverse Events (SAEs) | 4 complications classified per ISO14155 |
| DVR Plating System | Product Safety Based on Complications | Adverse Device Effects (ADEs) | 11 complications classified per ISO14155 |