Back to resultsPostoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures
Primary Purpose
Distal Radius Fracture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Splint
Formal Physical Therapy
Self directed physical therapy
Soft dressing (No Splint)
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture
Eligibility Criteria
Inclusion Criteria:
Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws.
- > 10 degrees of dorsal tilt
- Volar displacement (Volar Barton's type fracture)
- Shortening > 3 mm
Intra-articular displacement or step off > 2mm.
Exclusion Criteria:
- Ipsilateral upper limb concomitant fracture
- Fracture fixation other than volar locked plating and screws
- Dislocation or neurologic injury
- Gustilo-Anderson grade III open fractures
Sites / Locations
- NYU LangoneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Delayed mobilization/Formal physical therapy group
Immediate mobilization/self guided physical therapy group
Arm Description
Participants will be placed into a volar-based plaster splint post-operatively. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. After that, participants will be placed into a custom thermoplastic splint by a therapist. This will be worn for 5 weeks. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks. The splint will be removed only for formal and home physical therapy and hygiene.
Participants will be placed into a soft dressing after surgery. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. This group will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.
Outcomes
Primary Outcome Measures
Percentage of Loss of fixation
The loss of fixation will be measured by the change in radiologic outcomes (in degrees) from 2-week post-operative visit to follow-up visits.
Secondary Outcome Measures
Change in Patient comfort/pain (VAS)
This will be measured by the Visual Analogue Scale (VAS) which measures pain using a 10 point scale. On a scale of 1-10 where following pain scale is: no pain (0), mild pain(1-3), moderate pain (4-6), and severe pain (7-10).
Change in wrist range mobility
Range of motion will be measured using goniometers.
Change in wrist range mobility using DASH
This is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Change in Grip strength
Physical examinations through the study will record the grip strength (kgs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04324580
Brief Title
Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures
Official Title
Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures: Are They Necessary?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to see if splinting and formal physical therapy are necessary following surgical fixation (open reduction internal fixation) of distal radius fractures (broken wrist). Currently there is no consensus for post-operative protocol following fixation of distal radius fractures. The decision to splint (late mobilization) and prescribe formal physical therapy vs. not to splint (early mobilization) and use self-guided physical therapy is based on surgeon or institutional preference. The goal of this study is to determine if early mobilization leads to improved outcomes and decreased costs without increasing pain or the loss of hardware fixation.
Detailed Description
188 patients treated for distal radius fractures with open reduction internal fixation using volar locked plating will be split into two study groups: a group that is immobilized in a splint post operatively and given formal physical therapy and a group that does not receive either of these post operative interventions. The primary outcome will be loss of fixation. Secondary outcomes will include pain, cost, Quick Dash, range of motion, and grip strength. Data will be recorded at the pre-operative visit, as well as at post-operative visits at 2 weeks, 6 weeks, 3 months and 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delayed mobilization/Formal physical therapy group
Arm Type
Active Comparator
Arm Description
Participants will be placed into a volar-based plaster splint post-operatively. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. After that, participants will be placed into a custom thermoplastic splint by a therapist. This will be worn for 5 weeks. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks. The splint will be removed only for formal and home physical therapy and hygiene.
Arm Title
Immediate mobilization/self guided physical therapy group
Arm Type
Active Comparator
Arm Description
Participants will be placed into a soft dressing after surgery. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. This group will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Splint
Intervention Description
Participants will have their open reduction internal fixation of distal radius fractures treated with volar locked plating. for 2 weeks. Which will be replaced by a custom thermoplastic splint for 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Formal Physical Therapy
Intervention Description
Participants will also receive a prescription for formal physical therapy. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Self directed physical therapy
Intervention Description
Participants will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Soft dressing (No Splint)
Intervention Description
Participants will have their open reduction internal fixation of distal radius fractures placed in a soft dressing which will be kept in place for 2 weeks.
Primary Outcome Measure Information:
Title
Percentage of Loss of fixation
Description
The loss of fixation will be measured by the change in radiologic outcomes (in degrees) from 2-week post-operative visit to follow-up visits.
Time Frame
2 weeks, 4 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in Patient comfort/pain (VAS)
Description
This will be measured by the Visual Analogue Scale (VAS) which measures pain using a 10 point scale. On a scale of 1-10 where following pain scale is: no pain (0), mild pain(1-3), moderate pain (4-6), and severe pain (7-10).
Time Frame
Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks
Title
Change in wrist range mobility
Description
Range of motion will be measured using goniometers.
Time Frame
2 weeks, 4 weeks, 12 weeks, 24 weeks
Title
Change in wrist range mobility using DASH
Description
This is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Time Frame
2 weeks, 4 weeks, 12 weeks, 24 weeks
Title
Change in Grip strength
Description
Physical examinations through the study will record the grip strength (kgs)
Time Frame
2 weeks, 4 weeks, 12 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws.
> 10 degrees of dorsal tilt
Volar displacement (Volar Barton's type fracture)
Shortening > 3 mm
Intra-articular displacement or step off > 2mm.
Exclusion Criteria:
Ipsilateral upper limb concomitant fracture
Fracture fixation other than volar locked plating and screws
Dislocation or neurologic injury
Gustilo-Anderson grade III open fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jadie DeTolla, MD
Phone
631-786-4552
Email
jadie.detolla@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Izard
Phone
414-737-6461
Email
paul.izard@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadie De Tolla, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadie De Tolla
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to jadie.detolla@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures
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