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NCT Number: NCT04324580

Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

splint

Other

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.

Formal Physical Therapy

Behavioral

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.

Self directed physical therapy

Behavioral

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.

Soft dressing (No Splint)

Other

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 outcomes

  1. Percentage of Loss of fixation

    Time frame: 2 weeks, 4 weeks, 12 weeks, 24 weeks

    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 outcomes

  1. Change in Patient comfort/pain (VAS)

    Time frame: Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks

    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).

  2. Change in wrist range mobility

    Time frame: 2 weeks, 4 weeks, 12 weeks, 24 weeks

    Range of motion will be measured using goniometers.

  3. Change in wrist range mobility using DASH

    Time frame: 2 weeks, 4 weeks, 12 weeks, 24 weeks

    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.

  4. Change in Grip strength

    Time frame: 2 weeks, 4 weeks, 12 weeks, 24 weeks

    Physical examinations through the study will record the grip strength (kgs)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures: Are They Necessary?

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2020
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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