Distal Radius FracturesNCT06343467
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?
A study testing Generic Volar Locking Plate and Conventional Volar Locking Plate in people with Distal Radius Fractures, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Generic Volar Locking Plate and Conventional Volar Locking Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Isolated distal radius fracture
- Treated surgically with a volar locking plate
Who cannot join
- Volar locking plate not used
- Additional fixation was used
- Polytrauma (non-isolated injury)
- Open fracture
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generic Volar Locking Plate Use in Distal Radius Fractures: A Prospective Randomized Study to Evaluate Clinical Outcomes and Cost Reduction
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.
Read the 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.
- Conditions
- Distal Radius Fractures
- Being tested
- Generic Volar Locking Plate, Conventional Volar Locking Plate
- Keywords
- Volar Locking Plate, Generic Implants
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Volar Locking PlateDevice
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 Volar Locking PlateDevice
Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm.
| Study group | Role | What they receive |
|---|---|---|
| Generic Implant | Experimental | Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged. Receives: Device: Generic Volar Locking Plate |
| Conventional Implant | Active comparator | 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. Receives: Device: Conventional Volar Locking Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Reoperation Rate
Reoperation for any reason postoperatively within 90 days after the date of surgery.
Measured: Within 90 days postoperatively
90-day Readmission Rate
Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.
Measured: Within 90 days postoperatively
90-day Mortality Rate
Patient death at any point within 90 days after the date of surgery.
Measured: Within 90 days postoperatively
Secondary outcomes (3)
Implant Cost
The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.
Measured: Day of Surgery
Tourniquet Time
The total time in minutes from tourniquet inflation to deflation for a surgical case.
Measured: From tourniquet inflation to deflation during the procedure.
Estimated Blood Loss
Estimated blood loss for the surgical case as reported by the surgeon in milliliters.
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Cunningham, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343467
- Sponsor's protocol ID
- A17-376
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This data will remain confidential and de-identified on our institution's servers.
Publications
Walker JA, Althausen PL. Surgeon Attitudes Regarding the Use of Generic Implants: An OTA Survey Study. J Orthop Trauma. 2016 Dec;30 Suppl 5:S27-S31. doi: 10.1097/BOT.0000000000000722.
PubMed 27870671Waldrop VH, Laverty DC, Bozic KJ. Value-based Healthcare: Increasing Value by Reducing Implant-related Health Care Costs. Clin Orthop Relat Res. 2019 Feb;477(2):281-283. doi: 10.1097/01.blo.0000534683.24250.9c. No abstract available.
PubMed 29762154Miner HR, Slover JD, Koenig KM. Price Transparency and Consumer Perceptions of Generic and Brand-name Implants in Orthopaedic Surgery. Arch Bone Jt Surg. 2022 Sep;10(9):791-797. doi: 10.22038/ABJS.2022.51855.2558.
PubMed 36246025Mcphillamy A, Gurnea TP, Moody AE, Kurnik CG, Lu M. The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center. J Orthop Trauma. 2016 Dec;30 Suppl 5:S32-S36. doi: 10.1097/BOT.0000000000000721.
PubMed 27870672Khoo KM, Kim GW, Lindvall EM, Martirosian AK. Outcomes and Cost Comparison Between Generic and Conventional Cephalomedullary Nails in the Treatment of Peritrochanteric Femur Fractures. J Am Acad Orthop Surg. 2022 Feb 1;30(3):119-124. doi: 10.5435/JAAOS-D-21-00024.
PubMed 34715691Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. A Case Series of Surgically Treated Distal Radius Fractures: Implant Costs and Their Effect on Patient Outcomes. J Am Acad Orthop Surg Glob Res Rev. 2023 Jul 7;7(7):e23.00026. doi: 10.5435/JAAOSGlobal-D-23-00026. eCollection 2023 Jul 1.
PubMed 37428150Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. Implant cost variation in surgically treated distal radius fractures. J Orthop. 2023 Apr 7;39:45-49. doi: 10.1016/j.jor.2023.04.003. eCollection 2023 May.
PubMed 37125012
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generic Volar Locking Plate Use in Distal Radius Fractures: A Prospective Randomized Study to Evaluate Clinical Outcomes and Cost Reduction
- ClinicalTrials.gov ID
- NCT06343467
- Acronym / sponsor ID
- A17-376
- Conditions
- Distal Radius Fractures
- Keywords
- Volar Locking Plate, Generic Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months.
| Arm | Type | Receives |
|---|---|---|
| Generic Implant | Experimental | Device: Generic Volar Locking PlatePatients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged. |
| Conventional Implant | Active comparator | Device: Conventional Volar Locking PlatePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Isolated distal radius fracture
- Treated surgically with a volar locking plate
Key exclusion criteria (5 listed)
- Volar locking plate not used
- Additional fixation was used
- Polytrauma (non-isolated injury)
- Open fracture
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic Volar Locking PlateApplication 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. | Device | Generic Implant |
| Conventional Volar Locking PlateApplication of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm. | Device | Conventional Implant |
Primary outcome
90-day Reoperation Rate
Time frame: Within 90 days postoperatively
Reoperation for any reason postoperatively within 90 days after the date of surgery.
90-day Readmission Rate
Time frame: Within 90 days postoperatively
Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.
90-day Mortality Rate
Time frame: Within 90 days postoperatively
Patient death at any point within 90 days after the date of surgery.
3 secondary outcomes
Implant Cost
Time frame: Day of Surgery
Tourniquet Time
Time frame: From tourniquet inflation to deflation during the procedure.
Estimated Blood Loss
Time frame: Day of Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27870671Walker JA, Althausen PL. Surgeon Attitudes Regarding the Use of Generic Implants: An OTA Survey Study. J Orthop Trauma. 2016 Dec;30 Suppl 5:S27-S31. doi: 10.1097/BOT.0000000000000722.
- Background: PubMed 29762154Waldrop VH, Laverty DC, Bozic KJ. Value-based Healthcare: Increasing Value by Reducing Implant-related Health Care Costs. Clin Orthop Relat Res. 2019 Feb;477(2):281-283. doi: 10.1097/01.blo.0000534683.24250.9c. No abstract available.
- Background: PubMed 36246025Miner HR, Slover JD, Koenig KM. Price Transparency and Consumer Perceptions of Generic and Brand-name Implants in Orthopaedic Surgery. Arch Bone Jt Surg. 2022 Sep;10(9):791-797. doi: 10.22038/ABJS.2022.51855.2558.
- Background: PubMed 27870672Mcphillamy A, Gurnea TP, Moody AE, Kurnik CG, Lu M. The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center. J Orthop Trauma. 2016 Dec;30 Suppl 5:S32-S36. doi: 10.1097/BOT.0000000000000721.
- Background: PubMed 34715691Khoo KM, Kim GW, Lindvall EM, Martirosian AK. Outcomes and Cost Comparison Between Generic and Conventional Cephalomedullary Nails in the Treatment of Peritrochanteric Femur Fractures. J Am Acad Orthop Surg. 2022 Feb 1;30(3):119-124. doi: 10.5435/JAAOS-D-21-00024.
- Background: PubMed 37428150Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. A Case Series of Surgically Treated Distal Radius Fractures: Implant Costs and Their Effect on Patient Outcomes. J Am Acad Orthop Surg Glob Res Rev. 2023 Jul 7;7(7):e23.00026. doi: 10.5435/JAAOSGlobal-D-23-00026. eCollection 2023 Jul 1.
- Background: PubMed 37125012Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. Implant cost variation in surgically treated distal radius fractures. J Orthop. 2023 Apr 7;39:45-49. doi: 10.1016/j.jor.2023.04.003. eCollection 2023 May.
- Individual participant dataSharing planned: No. This data will remain confidential and de-identified on our institution's servers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Cunningham, MD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic Volar Locking Plate and Conventional Volar Locking Plate in people with Distal Radius Fractures, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Reoperation Rate (time frame: Within 90 days postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343467, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.