Early Active Finger Exercises in Replanted Fingers | NCT03383640

Studies
Early Active Finger Exercises in Replanted Fingers

NCT03383640

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Dec 26, 2017Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Amputation

Interventions

Active exercises

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Jan 5, 2021Estimated

First Submitted Date

Dec 15, 2017

First Submission Date that Met QC Criteria

Dec 19, 2017

First Posted Date

Dec 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2017

Last Update Posted Date

Dec 26, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johanne Korslund, Doctor, orthopaedic surgeon, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Control Group: Standardized post operative rehabilitation, where active exercises of the replanted digits is postponed until radiologic healing of the amputated bone.
Intervention	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active exercises	Other	Active flexion movements every waking hour of the replanted digits	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Quick-DASH	Upper extremity function score (patient related outcome measure)	12 months
VAS Pain	Visual Analogue Score Pain	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johanne Korslund, Cand.med	Contact	004795961393		johanne.korslund@ous-hf.no
Magne Røkkum, PhD	Contact	004723076025		mrokkum@ous-hf.no

Overall Officials

Not provided

Locations

Not provided