NCT02720055

Brief Summary

A randomised controlled trial to compare two different rehabilitation work books used in patients with wrist fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

March 21, 2016

Last Update Submit

March 11, 2019

Conditions

Fractures, Bone

Keywords

Distal Radius FractureOutcomesPsychological Intervention

Outcome Measures

Primary Outcomes (1)

  • Disability of Arm Shoulder and Hand

    Patient reported outcome measure validated for upper limb injuries.

    6 months

Secondary Outcomes (4)

  • Objective wrist function

    6 months

  • Patient satisfaction

    6 months

  • Illness Perception Questionnaire - revised

    6 months

  • Complications

    6 months

Study Arms (2)

Psychological Workbook

EXPERIMENTAL

Psychological work book containing information and activities aimed at improving outcomes.

Other: Psychological workbook

Basic information workbook

ACTIVE COMPARATOR

Basic information which represents current practice

Other: Basic information workbook

Interventions

Psychological workbookOTHER
Psychological Workbook
Basic information workbookOTHER

Basic rehabilitation information that represents current practice.

Basic information workbook

Eligibility Criteria

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

You may qualify if:

  • Isolated distal radius fracture undergoing management with manipulation and cast / cast alone / operative management.
  • Age 18 and over. No upper age limit

You may not qualify if:

  • Age \< 18
  • Cognitive impairment preventing completion of patient reported questionnaires
  • Non English speaking
  • Temporary residents unable to attend follow-up
  • Patients lacking capacity to consent and patients who loose capacity during the trial.
  • Paediatric fractures in skeletally immature patients.
  • Presentation and recruitment \> 3 weeks after injury
  • Patients with \> 1 fracture at time of injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics, Royal Infirmary Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Fractures, BoneWrist Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesWrist InjuriesArm Injuries

Study Officials

  • Stuart Goudie, MBChB

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 30, 2017

Last Updated

March 13, 2019

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

All data will be anonymised

Locations

GB(1)