Clinical Trial: Immobilization of Postoperative Distal Radius Fractures
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Immobilization of Postoperative Distal Radius Fractures
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 Summary:
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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Patient Rated Wrist Evaluation [ Time Frame: 2 weeks ]
- Patient Rated Wrist Evaluation [ Time Frame: 6 weeks ]
- Patient Rated Wrist Evaluation [ Time Frame: 12 weeks ]
- Patient Rated Wrist Evaluation [ Time Frame: 52 weeks ]
- Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score [ Time Frame: 2 weeks ]
- Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score [ Time Frame: 6 weeks ]
- Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score [ Time Frame: 12 weeks ]
- Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score [ Time Frame: 52 weeks ]
- Pain Scale (on a scale from 1-10) [ Time Frame: 2 weeks ]
- Pain Scale (on a scale from 1-10) [ Time Frame: 6 weeks ]
- Pain Scale (on a scale from 1-10) [ Time Frame: 12 weeks ]
- Pain Scale (on a scale from 1-10) [ Time Frame: 52 weeks ]
- Radiographic evidence of healing [ Time Frame: 2 weeks ]Do the x-rays show evidence of bone healing? Yes/No
- Radiographic evidence of healing [ Time Frame: 6 weeks ]Do the x-rays show evidence of bone healing? Yes/No
- Radiographic evidence of healing [ Time Frame: 12 weeks ]Do the x-rays show evidence of bone healing? Yes/No
- Complications that required further medical attention [ Time Frame: 2 weeks ]Were there any complications that required further medical attention within the first 6 month after surgery?
- Complications that required further medical attention [ Time Frame: 6 weeks ]Were there any complications that required further medical attention within the first 6 month after surgery?
- Complications that required further medical attention [ Time Frame: 12 weeks ]Were there any complications that required further medical attention within the first 6 month after surgery?
- Complications that required further medical attention [ Time Frame: 52 weeks ]Were there any complications that required further medical attention within the first 6 month after surgery?
- Range of Motion measured in degrees [ Time Frame: 2 weeks ]
- Range of Motion measured in degrees [ Time Frame: 6 weeks ]
- Range of Motion measured in degrees [ Time Frame: 12 weeks ]
- Range of Motion measured in degrees [ Time Frame: 52 weeks ]
- Grip Strength measured in kilograms [ Time Frame: 2 weeks ]
- Grip Strength measured in kilograms [ Time Frame: 6 weeks ]
- Grip Strength measured in kilograms [ Time Frame: 12 weeks ]
- Grip Strength measured in kilograms [ Time Frame: 52 weeks ]
- Pinch Strength measured in kilograms [ Time Frame: 2 weeks ]
- Pinch Strength measured in kilograms [ Time Frame: 6 weeks ]
- Pinch Strength measured in kilograms [ Time Frame: 12 weeks ]
- Pinch Strength measured in kilograms [ Time Frame: 52 weeks ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: June 2, 2016
Date Started: July 2016
Date Completion: December 2017
Last Updated: September 7, 2016
Last Verified: September 2016
