Recruiting

Observational Study

Sponsor:

Robert Wood Johnson Barnabas Health

Code:

NCT05033938

Conditions

Distal Radius Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Early Mobilization Protocol

Late Mobilization Protocol

Study Details

Brief summary:

The overall purpose of this study is to establish the utility of early mobilization in improving patient satisfaction following plate and screw fixation of wrist fractures. Subjects will have objective range of motion data collected and subjective survey data collected at 2 weeks, 6 weeks, 3 months, and 1 year after being randomized either to an early mobilization group that receives a removable wrist splint or a late mobilization group that is placed in a splint for 2 weeks post-operatively. The investigators expect that early wrist mobilization following locking plate fixation of wrist fractures will lead to an increase in postoperative patient satisfaction without a significant increase in complications.

Conditions

Distal Radius Fracture

Study ID

NCT05033938

Start date

Apr 5, 2021

Status verified date

Aug, 2021

Completion date

Apr 1, 2023

Anticipated

Primary completion date

Apr 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • DRF requiring volar plate fixation per physician investigator
  • No medical comorbidities which would prevent them from having surgery per physician investigator
  • Intra- or extra-articular DRF

Exclusion Criteria:

  • Open fractures
  • Comminuted fractures
  • Polytrauma
  • Bilateral DRFs
  • Previous contralateral wrist injury that could limit comparison
  • Additional ipsilateral fracture (except ulnar styloid - this will be recorded, but not an exclusion criteria)
  • Pathologic fractures
  • Additional fixation methods utilized (dorsal plate, K-wire, external fixator, etc.)
  • Bone graft use
  • Inability to comply with treatment protocol or follow-up

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Early Mobilization

Post-operatively subjects receive a removable wrist splint that can be taken off for early wrist mobilization

active comparator: Late Mobilization

Post-operatively subjects receive a splint and are not instructed to not move their wrist till the 2 week follow up visit.

Interventions

Early Mobilization Protocol

Subjects will be placed in a bulky soft dressing immediately after surgery. They will be made non-weight bearing, but active and passive motion of digits, forearm, elbow, and shoulder will be allowed with light functional tasks permitted as tolerated. Wrist motion within the soft dressing will be permitted as tolerated by patient. On postoperative day 3, patients will be advised to remove the dressing at home and begin home hand/wrist therapy. They will use a removable Velcro wrist splint for nighttime wear and strenuous activity. This splint can be removed during normal activities of daily living and therapy.

Late Mobilization Protocol

Subjects will be placed in a plaster volar resting splint. They will be made non-weight bearing, with use of digits for light functional tasks permitted. They will be given home exercises for their fingers but will not yet resume wrist motion

Primary outcome measure

  • Non-operative Hand Active Wrist Flexion [ Time Frame: 6 weeks ]
  • Non-operative Hand Active Wrist Flexion [ Time Frame: 3 months ]
  • Non-operative Hand Active Wrist Flexion [ Time Frame: 1 year ]
  • Non-operative Hand Passive Wrist Flexion [ Time Frame: 6 weeks ]
  • Non-operative Hand Passive Wrist Flexion [ Time Frame: 3 Months ]
  • Non-operative Hand Passive Wrist Flexion [ Time Frame: 1 Year ]
  • Non-operative Hand Active Wrist Extension [ Time Frame: 6 weeks ]
  • Non-operative Hand Active Wrist Extension [ Time Frame: 3 Months ]
  • Non-operative Hand Active Wrist Extension [ Time Frame: 1 Year ]
  • Non-operative Hand Passive Wrist Extension [ Time Frame: 6 weeks ]
  • Non-operative Hand Passive Wrist Extension [ Time Frame: 3 Months ]
  • Non-operative Hand Passive Wrist Extension [ Time Frame: 1 Year ]
  • Operative Hand Active Wrist Extension [ Time Frame: 6 weeks ]
  • Operative Hand Active Wrist Extension [ Time Frame: 3 Months ]
  • Operative Hand Active Wrist Extension [ Time Frame: 1 Year ]
  • Operative Hand Passive Wrist Extension [ Time Frame: 6 weeks ]
  • Operative Hand Passive Wrist Extension [ Time Frame: 3 Months ]
  • Operative Hand Passive Wrist Extension [ Time Frame: 1 Year ]
  • Operative Hand Active Wrist Flexion [ Time Frame: 6 weeks ]
  • Operative Hand Active Wrist Flexion [ Time Frame: 3 Months ]
  • Operative Hand Active Wrist Flexion [ Time Frame: 1 Year ]
  • Operative Hand Passive Wrist Flexion [ Time Frame: 6 weeks ]
  • Operative Hand Passive Wrist Flexion [ Time Frame: 3 Months ]
  • Operative Hand Passive Wrist Flexion [ Time Frame: 1 Year ]
  • Non-operative Hand Active Wrist Supination [ Time Frame: 6 Weeks ]
  • Non-operative Hand Active Wrist Supination [ Time Frame: 3 Months ]
  • Non-operative Hand Active Wrist Supination [ Time Frame: 1 Year ]
  • Non-operative Hand Passive Wrist Supination [ Time Frame: 6 Weeks ]
  • Non-operative Hand Passive Wrist Supination [ Time Frame: 3 Months ]
  • Non-operative Hand Passive Wrist Supination [ Time Frame: 1 Year ]
  • Operative Hand Active Wrist Supination [ Time Frame: 6 Weeks ]
  • Operative Hand Active Wrist Supination [ Time Frame: 3 months ]
  • Operative Hand Active Wrist Supination [ Time Frame: 1 Year ]
  • Operative Hand Passive Wrist Supination [ Time Frame: 6 Weeks ]
  • Operative Hand Passive Wrist Supination [ Time Frame: 3 Months ]
  • Operative Hand Passive Wrist Supination [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Bobby Varghese, MD

8324657112bv209@rwjms.rutgers.edu

Locations

University Orthopedics Associates

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

Bobby Varghese, MD

832-465-7112bv209@rwjms.rutgers.edu

Todd Alter, MD

tha8@rutgers.edu

More Information

Sponsor

Robert Wood Johnson Barnabas Health

Last update posted

Sep 5, 2021

Last verified

Aug, 2021

Keywords

  • volar locking plate
  • wrist fracture
  • plates and screws

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Wood Johnson Barnabas Health on 2021-09-05.