Distal Radius Fractures
Conditions
Keywords
Volar Locking Plate, Generic Implants
Brief summary
Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review.
Detailed description
Patients will be consented to surgery per a standard surgical consent form. Six surgeons who regularly perform distal radius fracture (DRF) ORIF are included (five hand and one orthopaedic trauma fellowship-trained). Per the practice protocol, patients will either be treated with a generic plate or a brand name plate as described above. Ultimately, the decision to use a generic volar locking plate (VLP) is left up to surgeon discretion. All surgical and follow-up data will be collected. Implants used, age at time of surgery, weight, height, gender, race, ethnicity, comorbidities (diabetes, heart disease, etc.), complications including, but not limited to: readmission, reoperation, non-union, wound dehiscence, and lab tests will be collected. This will be evaluated all within 90 days following surgery. Implants will be cross referenced with the institution's data base to determine cost. All data will be collected on a secure server and be kept password protected. The primary outcome was 90-day postoperative complications (readmissions, reoperations, and mortality rates) by implant vendor type (generic vs. conventional). Secondary outcomes consisted of implant costs, estimated blood loss, and tourniquet time. An a priori power analysis was conducted to estimate the minimum sample size needed to adequately detect a difference in reoperation rates with a large effect size (Cohen's d=0.8). At a Type I error rate of 0.05, a power of 80%, and a 1:1 group allocation, the estimated sample size was 36 patients (18 generic VLPs vs. 18 conventional VLPs). Statistical significance was set to p≤0.05.
Interventions
DEVICEGeneric Volar Locking Plate
Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.
DEVICEConventional Volar Locking Plate
Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm.
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients underwent the standard surgical consent, however the specific plate vendor that was used, was not specified by the physician.
Intervention model description
Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Isolated distal radius fracture * Treated surgically with a volar locking plate
Exclusion criteria
* Volar locking plate not used * Additional fixation was used * Polytrauma (non-isolated injury) * Open fracture * \<18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Reoperation Rate | Within 90 days postoperatively | Reoperation for any reason postoperatively within 90 days after the date of surgery. |
| 90-day Readmission Rate | Within 90 days postoperatively | Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery. |
| 90-day Mortality Rate | Within 90 days postoperatively | Patient death at any point within 90 days after the date of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Cost | Day of Surgery | The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants. |
| Tourniquet Time | From tourniquet inflation to deflation during the procedure. | The total time in minutes from tourniquet inflation to deflation for a surgical case. |
| Estimated Blood Loss | Day of Surgery | Estimated blood loss for the surgical case as reported by the surgeon in milliliters. |
Countries
United States
Participant flow
Pre-assignment details
Detailed physical examination of patient with radiographic evaluation of distal radius fracture and indication for volar locking plate open reduction and internal fixation. Patients with open fracture observed on physical examination, polytrauma (any other fracture or medical instability), metaphyseal extension of the fracture, age less than 18 years, and fracture pattern not suitable for fixation with volar locking plate were excluded before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Generic Implant Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.
Generic Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm. | 19 |
| Conventional Implant Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.
Conventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm. | 47 |
| Total | 66 |
Baseline characteristics
| Characteristic | Conventional Implant | Total | Generic Implant |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 26 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 40 Participants | 13 Participants |
| Age, Continuous | 60.74 years STANDARD_DEVIATION 11.37 | 61.03 years STANDARD_DEVIATION 11.52 | 61.75 years STANDARD_DEVIATION 12.16 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 47 Participants | 66 Participants | 19 Participants |
| Sex: Female, Male Female | 43 Participants | 61 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 47 |
| other Total, other adverse events | 0 / 19 | 0 / 47 |
| serious Total, serious adverse events | 0 / 19 | 0 / 47 |
Outcome results
Primary
90-day Mortality Rate
Patient death at any point within 90 days after the date of surgery.
Time frame: Within 90 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Generic Implant | 90-day Mortality Rate | 0 Participants |
| Conventional Implant | 90-day Mortality Rate | 0 Participants |
Primary
90-day Readmission Rate
Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.
Time frame: Within 90 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Generic Implant | 90-day Readmission Rate | 0 Participants |
| Conventional Implant | 90-day Readmission Rate | 0 Participants |
Primary
90-day Reoperation Rate
Reoperation for any reason postoperatively within 90 days after the date of surgery.
Time frame: Within 90 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Generic Implant | 90-day Reoperation Rate | 0 Participants |
| Conventional Implant | 90-day Reoperation Rate | 0 Participants |
Secondary
Estimated Blood Loss
Estimated blood loss for the surgical case as reported by the surgeon in milliliters.
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Generic Implant | Estimated Blood Loss | 13.3 milliliters | Standard Deviation 10.2 |
| Conventional Implant | Estimated Blood Loss | 13.2 milliliters | Standard Deviation 6.8 |
Secondary
Implant Cost
The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Generic Implant | Implant Cost | 702.38 United States Dollars | Standard Deviation 47.83 |
| Conventional Implant | Implant Cost | 1348.61 United States Dollars | Standard Deviation 100.77 |
Secondary
Tourniquet Time
The total time in minutes from tourniquet inflation to deflation for a surgical case.
Time frame: From tourniquet inflation to deflation during the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Generic Implant | Tourniquet Time | 49.05 minutes | Standard Deviation 19.2 |
| Conventional Implant | Tourniquet Time | 45.06 minutes | Standard Deviation 12.84 |