Trial Outcomes & Findings for Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? (NCT NCT06343467)
NCT ID: NCT06343467
Last Updated: 2024-08-28
Results Overview
Reoperation for any reason postoperatively within 90 days after the date of surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
Within 90 days postoperatively
Results posted on
2024-08-28
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
47
|
|
Overall Study
COMPLETED
|
19
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=66 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=19 Participants
|
27 Participants
n=47 Participants
|
40 Participants
n=66 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=19 Participants
|
20 Participants
n=47 Participants
|
26 Participants
n=66 Participants
|
|
Age, Continuous
|
61.75 years
STANDARD_DEVIATION 12.16 • n=19 Participants
|
60.74 years
STANDARD_DEVIATION 11.37 • n=47 Participants
|
61.03 years
STANDARD_DEVIATION 11.52 • n=66 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=19 Participants
|
43 Participants
n=47 Participants
|
61 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=19 Participants
|
4 Participants
n=47 Participants
|
5 Participants
n=66 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
47 Participants
n=47 Participants
|
66 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: Within 90 days postoperativelyReoperation for any reason postoperatively within 90 days after the date of surgery.
Outcome measures
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
|---|---|---|
|
90-day Reoperation Rate
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 90 days postoperativelyReadmission to the hospital for any reason postoperatively within 90 days after the date of surgery.
Outcome measures
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
|---|---|---|
|
90-day Readmission Rate
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 90 days postoperativelyPatient death at any point within 90 days after the date of surgery.
Outcome measures
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
|---|---|---|
|
90-day Mortality Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day of SurgeryThe total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.
Outcome measures
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
|---|---|---|
|
Implant Cost
|
702.38 United States Dollars
Standard Deviation 47.83
|
1348.61 United States Dollars
Standard Deviation 100.77
|
SECONDARY outcome
Timeframe: From tourniquet inflation to deflation during the procedure.The total time in minutes from tourniquet inflation to deflation for a surgical case.
Outcome measures
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
|---|---|---|
|
Tourniquet Time
|
49.05 minutes
Standard Deviation 19.2
|
45.06 minutes
Standard Deviation 12.84
|
SECONDARY outcome
Timeframe: Day of SurgeryEstimated blood loss for the surgical case as reported by the surgeon in milliliters.
Outcome measures
| Measure |
Generic Implant
n=19 Participants
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.
|
Conventional Implant
n=47 Participants
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.
|
|---|---|---|
|
Estimated Blood Loss
|
13.3 milliliters
Standard Deviation 10.2
|
13.2 milliliters
Standard Deviation 6.8
|
Adverse Events
Generic Implant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Implant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Megan Reams; Director of Orthopaedic Research
TRIA Orthopedic Center
Phone: (952) 806-5329
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place