NCT00816998

Brief Summary

Hypothesis : Early active range of motion protocol after open reduction and internal fixation of a distal radius fracture with a volar fixed angle locking plate results in earlier return of functional motion, earlier return to work and improved functional outcomes compared delayed mobilization. Specific Aim: To compare early range of motion versus delayed motion protocol in distal radius fractures treated with open reduction and internal fixation with a volar fixed angle locking plate with respect to time to fracture union, range of motion, functional outcome measures, return to work and complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

3.3 years

First QC Date

January 5, 2009

Last Update Submit

April 6, 2011

Conditions

Radius Fractures

Keywords

Radius fractures

Outcome Measures

Primary Outcomes (1)

  • Range of motion measurements

    at each study visit

Secondary Outcomes (5)

  • Pinch strength

    at each study visit

  • Grip strength

    at each study visit

  • Pain

    at each study visit

  • Return to work

    at each study visit

  • Scores of DASH & PRWE questionnaires

    at each study visit

Study Arms (2)

Early

OTHER

Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery

Procedure: Physical therapy

Delayed

OTHER

Participants randomized to this group will begin physical therapy of their fractured wrist approximately 6 weeks from their surgery. This is the approximate time frame in which therapy begins for patients not involved in the study. The term Delayed refers to therapy being delayed in starting from those in the study who begin therapy at one week post-operatively, not a delay in current care practice.

Procedure: Physical therapy

Interventions

Physical TherapyPROCEDURE

Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture

DelayedEarly

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The following criteria must be met to be enrolled:
  • Have a closed unstable distal radius fracture
  • Have a fracture classified as an AO Type A or C fracture, with or without an ulnar styloid fracture
  • Be a male or non-pregnant female at least 18 years of age.
  • Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
  • Have the ability to understand and provide written authorization for use and disclosure of personal health information

You may not qualify if:

  • Participants are excluded if they:
  • Have any of the following conditions
  • Concomitant contralateral or ipsilateral upper extremity fractures
  • Ipsilateral ulna (excluding styloid) fracture
  • Open, multi-fragmentary fracture
  • Artery or Nerve injury secondary to fracture
  • Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment
  • Are currently on chemotherapy or radiation therapy
  • A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
  • A history of uncontrolled diabetes
  • Are unable to provide consent for the study
  • Are unable to make the follow-up appointments required of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Radius Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Alexander Y. Shin, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

October 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations

US(1)