Flexor Tendon InjuryNCT02361814
The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair
A study testing The use of amnionic membrane allograft in people with Flexor Tendon Injury, run by Tampere University at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Tendon Injury
- What is being tested?
- The use of amnionic membrane allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair: a Pilot Study
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.
Read the detailed description
The treatment of flexor tendon transection consists of surgical apposition of the lacerated tendon ends using non-absorbable sutures. Main complications which result in poor outcome of the tendon repair are the rupture of the tendon apposition or substantial adhesion formation between the two tendons or the tendon and the fibro-osseous canal. Adhesion formation is presumed to be a byproduct of the tendon healing. In the course of last 70 decades, the preventive effects of several pharmacological agents and mechanical barriers on adhesion formation have been investigated with some promising findings. One of the mechanical barriers that has been proposed to be suitable for adhesion prevention is human amniotic membrane allograft. However, there are no clinical studies evaluating the use of amniotic membrane in flexor tendon repair.
This is a pilot study for the forthcoming randomized controlled study. The objectives of the pilot study are: 1) to test the handleability of the human amniotic membrane allograft in flexor tendon sheath reconstruction in conjunction with flexor tendon repair, 2) to elucidate the possible adverse effects related to the use of amniotic membrane in flexor the sheath, and 3) to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation. The hypothesis of the pilot study is that the application of the human amniotic membrane allograft in tendon sheath reconstruction in flexor tendon injury patients is technically feasible and results in no adverse effects to the patient.
A total of 10 patients with an acute flexor tendon injury will be included in the pilot study. After conventional tendoraphia, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath. The primary outcome measure is total range of movement after 6 months of the surgery.
- Conditions
- Flexor Tendon Injury
- Being tested
- The use of amnionic membrane allograft
- Keywords
- flexor tendon, finger, amniotic membrane, allograft, tendon injury
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of amnionic membrane allograftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: The use of amnionic membrane allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total range of movement of the injured finger
Measured: 6 months
Secondary outcomes (4)
Total range of movement of the injured finger
Measured: 2, 4, and 8 weeks
Rupture of the repair
Measured: 2, 4, 8 weeks, and 6 months
Postoperative infection
Measured: 2, 4, 8 weeks, and 6 months
QuickDASH -score
Measured: 2, 4, 8 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Unfavorable results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Central Finland Hospital District
- Responsible party
- Principal investigator, Olli Leppänen, Tampere University
- Investigators
- Harry Göransson, M.D., Ph.D., Study chair, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361814
- Sponsor's protocol ID
- R15002
- Status last verified
- Jun 2017
- First submitted
- 3 Feb 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair: a Pilot Study
- ClinicalTrials.gov ID
- NCT02361814
- Acronym / sponsor ID
- R15002
- Conditions
- Flexor Tendon Injury
- Keywords
- flexor tendon, finger, amniotic membrane, allograft, tendon injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unfavorable results
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Central Finland Hospital District
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment of flexor tendon transection consists of surgical apposition of the lacerated tendon ends using non-absorbable sutures. Main complications which result in poor outcome of the tendon repair are the rupture of the tendon apposition or substantial adhesion formation between the two tendons or the tendon and the fibro-osseous canal. Adhesion formation is presumed to be a byproduct of the tendon healing. In the course of last 70 decades, the preventive effects of several pharmacological agents and mechanical barriers on adhesion formation have been investigated with some promising findings. One of the mechanical barriers that has been proposed to be suitable for adhesion prevention is human amniotic membrane allograft. However, there are no clinical studies evaluating the use of amniotic membrane in flexor tendon repair.
This is a pilot study for the forthcoming randomized controlled study. The objectives of the pilot study are: 1) to test the handleability of the human amniotic membrane allograft in flexor tendon sheath reconstruction in conjunction with flexor tendon repair, 2) to elucidate the possible adverse effects related to the use of amniotic membrane in flexor the sheath, and 3) to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation. The hypothesis of the pilot study is that the application of the human amniotic membrane allograft in tendon sheath reconstruction in flexor tendon injury patients is technically feasible and results in no adverse effects to the patient.
A total of 10 patients with an acute flexor tendon injury will be included in the pilot study. After conventional tendoraphia, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath. The primary outcome measure is total range of movement after 6 months of the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane allograft group | Experimental | Procedure: The use of amnionic membrane allograftAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The use of amnionic membrane allograftAfter 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 or surgery | Amniotic membrane allograft group |
Primary outcome
Total range of movement of the injured finger
Time frame: 6 months
4 secondary outcomes
Total range of movement of the injured finger
Time frame: 2, 4, and 8 weeks
Rupture of the repair
Time frame: 2, 4, 8 weeks, and 6 months
Postoperative infection
Time frame: 2, 4, 8 weeks, and 6 months
QuickDASH -score
Time frame: 2, 4, 8 weeks, and 6 months
Results and safety
The study was stopped early (reason given: Unfavorable results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Göransson, M.D., Ph.D. study chair
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The use of amnionic membrane allograft in people with Flexor Tendon Injury, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unfavorable results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total range of movement of the injured finger (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.