Immobilization of Postoperative Distal Radius Fractures

NCT02802774 | Terminated

• 1 other identifier: 2016033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Distal Radius Fractures

Keywords

Post-operative treatment

Outcome Measures

Primary Outcomes (8)

• Patient Rated Wrist Evaluation

  24 weeks

• Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score

  24 weeks

• Pain Scale (on a scale from 1-10)

  24 weeks

• Grip Strength measured in kilograms

  24 weeks

• Pinch Strength measured in kilograms

  24 weeks

• Range of Motion measured in degrees

  24 weeks

• Radiographic evidence of healing

  Do the x-rays show evidence of bone healing? Yes/No

  24 weeks

• 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 Outcomes (31)

• Patient Rated Wrist Evaluation

  2 weeks

• Patient Rated Wrist Evaluation

  6 weeks

• Patient Rated Wrist Evaluation

  12 weeks

• Patient Rated Wrist Evaluation

  52 weeks

• Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score

  2 weeks

Other Outcomes (1)

• Mobility Satisfaction (Extremely, Very, Somewhat, Not at all)

  2

Study Arms (3)

Plaster Splint

ACTIVE COMPARATOR

Other: Plaster Splint

Velcro Brace

ACTIVE COMPARATOR

Other: Velcro Brace

Soft Dressing

ACTIVE COMPARATOR

Other: Soft Dressing

Interventions

Plaster Splint OTHER

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.

Plaster Splint

Velcro Brace OTHER

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.

Velcro Brace

Soft Dressing OTHER

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.

Soft Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• extra and intra articular distal radius fractures treated with distal locking plates

You may not qualify if:

• patients with additional injuries to the ipsilateral wrist such as, distal radial ulnar joint (DRUJ) instability and associated unstable ulna fractures.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

Sierra Pacific Orthopaedic Center

Fresno, California, 93720, United States

Location

Community Medical Center

Fresno, California, 93721, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Nathan Hoekzema, MD

  UCSF - Fresno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 16, 2016
• Study Start: July 1, 2016
• Primary Completion: April 19, 2020
• Study Completion: April 19, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)