Immobilization of Postoperative Distal Radius Fractures
Primary Purpose
Distal Radius Fractures
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plaster Splint
Velcro Brace
Soft Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures focused on measuring Post-operative treatment
Eligibility Criteria
Inclusion Criteria:
- extra and intra articular distal radius fractures treated with distal locking plates
Exclusion Criteria:
- patients with additional injuries to the ipsilateral wrist such as, distal radial ulnar joint (DRUJ) instability and associated unstable ulna fractures.
Sites / Locations
- Sierra Pacific Orthopaedic Center
- Community Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Plaster Splint
Velcro Brace
Soft Dressing
Arm Description
Outcomes
Primary Outcome Measures
Patient Rated Wrist Evaluation
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Pain Scale (on a scale from 1-10)
Grip Strength measured in kilograms
Pinch Strength measured in kilograms
Range of Motion measured in degrees
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Secondary Outcome Measures
Patient Rated Wrist Evaluation
Patient Rated Wrist Evaluation
Patient Rated Wrist Evaluation
Patient Rated Wrist Evaluation
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Pain Scale (on a scale from 1-10)
Pain Scale (on a scale from 1-10)
Pain Scale (on a scale from 1-10)
Pain Scale (on a scale from 1-10)
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Range of Motion measured in degrees
Range of Motion measured in degrees
Range of Motion measured in degrees
Range of Motion measured in degrees
Grip Strength measured in kilograms
Grip Strength measured in kilograms
Grip Strength measured in kilograms
Grip Strength measured in kilograms
Pinch Strength measured in kilograms
Pinch Strength measured in kilograms
Pinch Strength measured in kilograms
Pinch Strength measured in kilograms
Full Information
NCT ID
NCT02802774
First Posted
June 2, 2016
Last Updated
March 17, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02802774
Brief Title
Immobilization of Postoperative Distal Radius Fractures
Official Title
Immobilization of Postoperative Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Not enough study participants
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 19, 2020 (Actual)
Study Completion Date
April 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The management of distal radius fractures has been in a state of evolution over the past 30 years. Treatment has become increasingly focused on obtaining a stable, internal construct for quick return to normal, daily activities. With the advent of volar locking plates, the wrist fracture is stable before the patient leaves the operating room. As surgical plate and screw constructs become more stable, the need for casting and splinting may be less.
The presumptive "next step" in operative management of distal radius fractures is to do away with the postoperative splint. A review of the available English language literature failed to reveal any studies evaluating the use of postoperative splinting and patient outcomes.
This prospective, randomized study was designed to investigate the use of temporary plaster splints versus removable over-the-counter splits versus soft dressings for post-operative treatment of extra-articular and intra-articular distal radius fractures. The patients will be followed for 12 months evaluating maintenance of fracture reduction and patient outcomes.
Detailed Description
A prospective study using multiple surgeons at multiple centers (Community Regional Medical Center and Sierra Pacific Orthopaedic Center) investigating post-operative management of extra and intra articular distal radius fractures treated with volar locking plates. Post-operative management for 2 weeks immediately following surgery will consist of placing 1/3 of patients in a short arm, custom-made, plaster splint, 1/3 with a removable Velcro wrist splint, and 1/3 with a soft dressing. The Velcro wrist brace group will be asked to wear the brace as much as possible during the two weeks and the soft dressing may be removed by the patient on the third day after surgery.
The custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place.
The Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding.
Patients in the soft dressing group will have non-stick gauze, 4x4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab.
Patients will be randomized using REDCap Randomization module after being consented to participate in the study by the primary investigator or sub-investigator. Each investigator will have the option during and/or after surgery to remove the patient from the group they have been randomized into and treat them as they see appropriate. These patients would be documented but removed from the study follow up.
Patient satisfaction will be evaluated subjectively with the PRWE (Patient-Rated Wrist Evaluation) as well as the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Radiographs will be taken at 2, 6, 12, and 24 weeks postoperatively to measure fracture alignment and healing. Patient reported pain level, range of motion, grip, and pinch strength will be recorded at each visit as well as at a final 1 year follow-up visit. Any complication will be noted. All of these visits are part of the standard of care. The only additional part of their visit would be the brief survey including the QuickDASH and PRWE that they complete with an orthopaedic surgery resident during their visit. In addition at the first follow up appointment at 2 weeks post-surgery, patients will be asked about their satisfaction with the mobility of their wrist and those in the Velcro brace will be asked how often they wore the brace. All data will be collected on a data collection sheet and then entered into a database
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Post-operative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plaster Splint
Arm Type
Active Comparator
Arm Title
Velcro Brace
Arm Type
Active Comparator
Arm Title
Soft Dressing
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Plaster Splint
Intervention Description
The custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place. Patients will wear the plaster splint for 2 weeks post-op.
Intervention Type
Other
Intervention Name(s)
Velcro Brace
Intervention Description
The Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding. Patients will be asked to wear the brace as much as possible for the first 2 weeks post-op.
Intervention Type
Other
Intervention Name(s)
Soft Dressing
Intervention Description
Patients in the soft dressing group will have non-stick gauze, 4X4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab. Patients wear the soft dressing for the first three days post-op.
Primary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation
Time Frame
24 weeks
Title
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time Frame
24 weeks
Title
Pain Scale (on a scale from 1-10)
Time Frame
24 weeks
Title
Grip Strength measured in kilograms
Time Frame
24 weeks
Title
Pinch Strength measured in kilograms
Time Frame
24 weeks
Title
Range of Motion measured in degrees
Time Frame
24 weeks
Title
Radiographic evidence of healing
Description
Do the x-rays show evidence of bone healing? Yes/No
Time Frame
24 weeks
Title
Complications that required further medical attention
Description
Were there any complications that required further medical attention within the first 6 month after surgery?
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation
Time Frame
2 weeks
Title
Patient Rated Wrist Evaluation
Time Frame
6 weeks
Title
Patient Rated Wrist Evaluation
Time Frame
12 weeks
Title
Patient Rated Wrist Evaluation
Time Frame
52 weeks
Title
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time Frame
2 weeks
Title
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time Frame
6 weeks
Title
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time Frame
12 weeks
Title
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time Frame
52 weeks
Title
Pain Scale (on a scale from 1-10)
Time Frame
2 weeks
Title
Pain Scale (on a scale from 1-10)
Time Frame
6 weeks
Title
Pain Scale (on a scale from 1-10)
Time Frame
12 weeks
Title
Pain Scale (on a scale from 1-10)
Time Frame
52 weeks
Title
Radiographic evidence of healing
Description
Do the x-rays show evidence of bone healing? Yes/No
Time Frame
2 weeks
Title
Radiographic evidence of healing
Description
Do the x-rays show evidence of bone healing? Yes/No
Time Frame
6 weeks
Title
Radiographic evidence of healing
Description
Do the x-rays show evidence of bone healing? Yes/No
Time Frame
12 weeks
Title
Complications that required further medical attention
Description
Were there any complications that required further medical attention within the first 6 month after surgery?
Time Frame
2 weeks
Title
Complications that required further medical attention
Description
Were there any complications that required further medical attention within the first 6 month after surgery?
Time Frame
6 weeks
Title
Complications that required further medical attention
Description
Were there any complications that required further medical attention within the first 6 month after surgery?
Time Frame
12 weeks
Title
Complications that required further medical attention
Description
Were there any complications that required further medical attention within the first 6 month after surgery?
Time Frame
52 weeks
Title
Range of Motion measured in degrees
Time Frame
2 weeks
Title
Range of Motion measured in degrees
Time Frame
6 weeks
Title
Range of Motion measured in degrees
Time Frame
12 weeks
Title
Range of Motion measured in degrees
Time Frame
52 weeks
Title
Grip Strength measured in kilograms
Time Frame
2 weeks
Title
Grip Strength measured in kilograms
Time Frame
6 weeks
Title
Grip Strength measured in kilograms
Time Frame
12 weeks
Title
Grip Strength measured in kilograms
Time Frame
52 weeks
Title
Pinch Strength measured in kilograms
Time Frame
2 weeks
Title
Pinch Strength measured in kilograms
Time Frame
6 weeks
Title
Pinch Strength measured in kilograms
Time Frame
12 weeks
Title
Pinch Strength measured in kilograms
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Mobility Satisfaction (Extremely, Very, Somewhat, Not at all)
Time Frame
2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
extra and intra articular distal radius fractures treated with distal locking plates
Exclusion Criteria:
patients with additional injuries to the ipsilateral wrist such as, distal radial ulnar joint (DRUJ) instability and associated unstable ulna fractures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Hoekzema, MD
Organizational Affiliation
UCSF - Fresno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sierra Pacific Orthopaedic Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Community Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share any individual participant data.
Learn more about this trial
Immobilization of Postoperative Distal Radius Fractures
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