Tendon InjuriesNCT01726855
Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap
An observational study of Tendon Injuries, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
The purpose of this study was to report a new method of flexor tendon repair in zone II with combined standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger volar for placement of a mechanical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- vascularized finger dorsal fascial flap
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jul 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients requiring flexor tendon repair or reconstruction within zoneⅡ
Who may be able to join
- patients requiring flexor tendon repair or reconstruction within zoneⅡ
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to report a new method of flexor tendon repair in zone II with combined standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger volar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair in zone II with this new technique were compared with those of 32 patients (Group B) with flexor tendon repair in zone II with standard modified Kessler technique. This new technique may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.
- Conditions
- Tendon Injuries
- Being tested
- vascularized finger dorsal fascial flap
- Keywords
- tendon repair
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascularized finger dorsal fascial flapProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| dorsal fascial flap | combined with standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger palmar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. Receives: Procedure: vascularized finger dorsal fascial flap | |
| standard modified Kessler technique | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the modified Strickland system
Measured: 3~12 months
degrees of the maximum active flexion at the distal interphalangeal joint
Measured: 3~12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726855
- Sponsor's protocol ID
- sun_rising
- Status last verified
- Nov 2012
- First submitted
- 11 Nov 2012
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap
- ClinicalTrials.gov ID
- NCT01726855
- Acronym / sponsor ID
- sun_rising
- Conditions
- Tendon Injuries
- Keywords
- tendon repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Nov 2012 (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 purpose of this study was to report a new method of flexor tendon repair in zone II with combined standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger volar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair in zone II with this new technique were compared with those of 32 patients (Group B) with flexor tendon repair in zone II with standard modified Kessler technique. This new technique may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dorsal fascial flap | – | Procedure: vascularized finger dorsal fascial flapcombined with standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger palmar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. |
| standard modified Kessler technique | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients requiring flexor tendon repair or reconstruction within zoneⅡ
Key inclusion criteria (1 listed)
- patients requiring flexor tendon repair or reconstruction within zoneⅡ
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| vascularized finger dorsal fascial flap | Procedure or surgery | dorsal fascial flap |
Primary outcome
the modified Strickland system
Time frame: 3~12 months
degrees of the maximum active flexion at the distal interphalangeal joint
Time frame: 3~12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendon Injuries, run by The Second Hospital of Tangshan at 1 site in China.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 22 Jan 2024. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the modified Strickland system (time frame: 3~12 months). The study lists 2 primary outcomes in all. 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 22 Jan 2024.