Early Active Finger Exercises in Replanted Fingers

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03383640
• Other study ID #: 2017/1282 D
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2017
• Last updated: December 19, 2017
• Start date: January 1, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: December 2017
• Source: Oslo University Hospital
• Contact: Johanne Korslund, Cand.med
• Phone: 004795961393
• Email: johanne.korslund[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 5, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• Active exercises
Active flexion movements every waking hour of the replanted digits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TAM	Total active movement of the interphalangeal joints	12 months
Secondary	Quick-DASH	Upper extremity function score (patient related outcome measure)	12 months
Secondary	VAS Pain	Visual Analogue Score Pain	12 months
Secondary	VAS Function	Visual Analogue Score Function	12 months
Secondary	Grip strength	Jamar dynanometer	12 months
Secondary	Key pinch	Jamar dynamometer	12 months