Clinical trial NCT02802774: Immobilization of Postoperative Distal Radius Fractures
Official title: Immobilization of Postoperative Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Distal Radius Fractures
Keywords: Post-operative treatment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Patient Rated Wrist Evaluation
timeFrame: 24 weeks
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
timeFrame: 24 weeks
measure: Pain Scale (on a scale from 1-10)
timeFrame: 24 weeks
measure: Grip Strength measured in kilograms
timeFrame: 24 weeks
measure: Pinch Strength measured in kilograms
timeFrame: 24 weeks
measure: Range of Motion measured in degrees
timeFrame: 24 weeks
measure: Radiographic evidence of healing
timeFrame: 24 weeks
measure: Complications that required further medical attention
timeFrame: 24 weeks
Secondary outcomes:
measure: Patient Rated Wrist Evaluation
timeFrame: 2 weeks
measure: Patient Rated Wrist Evaluation
timeFrame: 6 weeks
measure: Patient Rated Wrist Evaluation
timeFrame: 12 weeks
measure: Patient Rated Wrist Evaluation
timeFrame: 52 weeks
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
timeFrame: 2 weeks
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
timeFrame: 6 weeks
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
timeFrame: 12 weeks
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
timeFrame: 52 weeks
measure: Pain Scale (on a scale from 1-10)
timeFrame: 2 weeks
measure: Pain Scale (on a scale from 1-10)
timeFrame: 6 weeks
measure: Pain Scale (on a scale from 1-10)
timeFrame: 12 weeks
measure: Pain Scale (on a scale from 1-10)
timeFrame: 52 weeks
measure: Radiographic evidence of healing
timeFrame: 2 weeks
measure: Radiographic evidence of healing
timeFrame: 6 weeks
measure: Radiographic evidence of healing
timeFrame: 12 weeks
measure: Complications that required further medical attention
timeFrame: 2 weeks
measure: Complications that required further medical attention
timeFrame: 6 weeks
measure: Complications that required further medical attention
timeFrame: 12 weeks
measure: Complications that required further medical attention
timeFrame: 52 weeks
measure: Range of Motion measured in degrees
timeFrame: 2 weeks
measure: Range of Motion measured in degrees
timeFrame: 6 weeks
measure: Range of Motion measured in degrees
timeFrame: 12 weeks
measure: Range of Motion measured in degrees
timeFrame: 52 weeks
measure: Grip Strength measured in kilograms
timeFrame: 2 weeks
measure: Grip Strength measured in kilograms
timeFrame: 6 weeks
measure: Grip Strength measured in kilograms
timeFrame: 12 weeks
measure: Grip Strength measured in kilograms
timeFrame: 52 weeks
measure: Pinch Strength measured in kilograms
timeFrame: 2 weeks
measure: Pinch Strength measured in kilograms
timeFrame: 6 weeks
measure: Pinch Strength measured in kilograms
timeFrame: 12 weeks
measure: Pinch Strength measured in kilograms
timeFrame: 52 weeks
Other outcomes:
measure: Mobility Satisfaction (Extremely, Very, Somewhat, Not at all)
timeFrame: 2
Locations:
city: Fresno
country: United States
facility: Sierra Pacific Orthopaedic Center
state: California
city: Fresno
country: United States
facility: Community Medical Center
state: California
Study officials:
affiliation: UCSF - Fresno
name: Nathan Hoekzema, MD
role: PRINCIPAL_INVESTIGATOR
References: