Early Active Finger Exercises in Replanted Fingers

Will Early Active Finger Exercises in Replanted Fingers Improve Mobility? A Prospective Randomized Trial

A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Other: Active exercises

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 18 years
• Total or subtotal amputation injury of 1-4 of the four ulnar digits
• Injury distal to the MCP joint
• Must have injured flexor tendon which requires suture
• Must have a fracture
• Surgery done with a stable osteosynthesis with acceptable post-operative x-ray imaging
• The finger must have had a stable circulation for at least 5 days post-surgery

Exclusion Criteria:

• Arthrodesis/temporary fixation of the MCP joint
• Bilateral amputation injury
• Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
• Patients who cannot follow the planned controls

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Control Group: Standardized post operative rehabilitation, where active exercises of the replanted digits is postponed until radiologic healing of the amputated bone.
OTHER: Intervention; Intervention Group: Early active exercises of the replanted digits started between day 5 and 7 after surgery, as instructed by hand therapist	Other: Active exercises; Active flexion movements every waking hour of the replanted digits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAM	Total active movement of the interphalangeal joints	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick-DASH	Upper extremity function score (patient related outcome measure)	12 months
VAS Pain	Visual Analogue Score Pain	12 months
VAS Function	Visual Analogue Score Function	12 months
Grip strength	Jamar dynanometer	12 months
Key pinch	Jamar dynamometer	12 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): January 5, 2021

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (ACTUAL): December 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017/1282 D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No