Immobilization of Postoperative Distal Radius Fractures

Distal Radius Fractures Clinical Trial

Official title:

Immobilization of Postoperative Distal Radius Fractures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02802774
• Other study ID #: 2016033
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 19, 2020

Study information

• Verified date: March 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 19, 2020
• Est. primary completion date: April 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Plaster Splint
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.
• Velcro Brace
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.
• Soft Dressing
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.

Locations

Country	Name	City	State
United States	Community Medical Center	Fresno	California
United States	Sierra Pacific Orthopaedic Center	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mobility Satisfaction (Extremely, Very, Somewhat, Not at all)		2
Primary	Patient Rated Wrist Evaluation		24 weeks
Primary	Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score		24 weeks
Primary	Pain Scale (on a scale from 1-10)		24 weeks
Primary	Grip Strength measured in kilograms		24 weeks
Primary	Pinch Strength measured in kilograms		24 weeks
Primary	Range of Motion measured in degrees		24 weeks
Primary	Radiographic evidence of healing	Do the x-rays show evidence of bone healing? Yes/No	24 weeks
Primary	Complications that required further medical attention	Were there any complications that required further medical attention within the first 6 month after surgery?	24 weeks
Secondary	Patient Rated Wrist Evaluation		2 weeks
Secondary	Patient Rated Wrist Evaluation		6 weeks
Secondary	Patient Rated Wrist Evaluation		12 weeks
Secondary	Patient Rated Wrist Evaluation		52 weeks
Secondary	Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score		2 weeks
Secondary	Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score		6 weeks
Secondary	Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score		12 weeks
Secondary	Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score		52 weeks
Secondary	Pain Scale (on a scale from 1-10)		2 weeks
Secondary	Pain Scale (on a scale from 1-10)		6 weeks
Secondary	Pain Scale (on a scale from 1-10)		12 weeks
Secondary	Pain Scale (on a scale from 1-10)		52 weeks
Secondary	Radiographic evidence of healing	Do the x-rays show evidence of bone healing? Yes/No	2 weeks
Secondary	Radiographic evidence of healing	Do the x-rays show evidence of bone healing? Yes/No	6 weeks
Secondary	Radiographic evidence of healing	Do the x-rays show evidence of bone healing? Yes/No	12 weeks
Secondary	Complications that required further medical attention	Were there any complications that required further medical attention within the first 6 month after surgery?	2 weeks
Secondary	Complications that required further medical attention	Were there any complications that required further medical attention within the first 6 month after surgery?	6 weeks
Secondary	Complications that required further medical attention	Were there any complications that required further medical attention within the first 6 month after surgery?	12 weeks
Secondary	Complications that required further medical attention	Were there any complications that required further medical attention within the first 6 month after surgery?	52 weeks
Secondary	Range of Motion measured in degrees		2 weeks
Secondary	Range of Motion measured in degrees		6 weeks
Secondary	Range of Motion measured in degrees		12 weeks
Secondary	Range of Motion measured in degrees		52 weeks
Secondary	Grip Strength measured in kilograms		2 weeks
Secondary	Grip Strength measured in kilograms		6 weeks
Secondary	Grip Strength measured in kilograms		12 weeks
Secondary	Grip Strength measured in kilograms		52 weeks
Secondary	Pinch Strength measured in kilograms		2 weeks
Secondary	Pinch Strength measured in kilograms		6 weeks
Secondary	Pinch Strength measured in kilograms		12 weeks
Secondary	Pinch Strength measured in kilograms		52 weeks