NCT02361814

Brief Summary

The objective of this pilot study is to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation after flexor tendon repair.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

February 3, 2015

Last Update Submit

June 25, 2017

Conditions

Flexor Tendon Injury

Keywords

flexor tendonfingeramniotic membraneallografttendon injury

Outcome Measures

Primary Outcomes (1)

  • Total range of movement of the injured finger

    6 months

Secondary Outcomes (4)

  • Total range of movement of the injured finger

    2, 4, and 8 weeks

  • Rupture of the repair

    2, 4, 8 weeks, and 6 months

  • Postoperative infection

    2, 4, 8 weeks, and 6 months

  • QuickDASH -score

    2, 4, 8 weeks, and 6 months

Study Arms (1)

Amniotic membrane allograft group

EXPERIMENTAL

After the conventional flexor tendon repair, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath.

Procedure: The use of amnionic membrane allograft

Interventions

The use of amnionic membrane allograftPROCEDURE

After the conventional flexor tendon repair, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath.

Amniotic membrane allograft group

Eligibility Criteria

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

You may qualify if:

  • Acute flexor tendon transection in zone 2 in digits 2, 3, 4, or 5 (diagnosed within 1 week after the injury)
  • Age over 18
  • Patient's willingness to participate in the study

You may not qualify if:

  • Tendon transection within 8 mm of its distal insertion (requiring reinsertion)
  • Soft-tissue loss, severe crush, fracture, palmar plate injury, patient requiring revascularization
  • Cognitive impairment or other factors (prisoner, military serviceman) which may affect one's decision making
  • Substance abuse
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tampere

Tampere, Finland

Location

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Harry Göransson, M.D., Ph.D.

    Tampere University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 12, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

FI(1)