Cut Flexor HandNCT04089124
Compare the Outcomes of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT
A study testing surgery of zone II cut flexor repair in people with Cut Flexor Hand and Walant, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison between results of repair of cut flexor zone II under General anesthesia and Walant Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Cut Flexor Hand, Walant, General Anesthesia
- What is being tested?
- surgery of zone II cut flexor repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Jun 2022
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute zone II flexor tendon injuries of the hand in both genders in medial four fingers.
- Cooperative patients aged between 16-60 years.
- Sharp mechanism of injury
- Single level injury
Who cannot join
- Age less than sixteen years old or more than sixty years old .
- Associated fractures close to the tendon injury.
- Vascular injury requiring revascularization
- Multiple level injury
- Combined flexor and extensor laceration
- Insufficient skin and soft tissue coverage
- Tendon substance loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Compare the Outcomes Of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia No Tourniquet
Comparison between results of repair of cut flexor zone II under General anesthesia and Walant
Read the detailed description
Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management \&mobilization to prevent adhesions and improve gliding but risk of rupture.
The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to 14th century (area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery and anesthesia repair is possible with good results.
General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.
WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .
This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.
2)sheath and pulley damage are minimized, as flexor tendons are repaired through small transverse sheathotomy incisions 3) the surgeon can interview the patient during the procedure and assess the ability to comply with the postoperative regimen 4) the risks of general anesthesia are avoided in most patients. Negative effects of general anesthesia include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general anesthesia,and others
- Conditions
- Cut Flexor Hand, Walant, General Anesthesia
- Being tested
- surgery of zone II cut flexor repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery of zone II cut flexor repairProcedure or surgery
we will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture
| Study group | Role | What they receive |
|---|---|---|
| repair using General anesthesia ( control group) | Other | Surgery repair zone II under GA Receives: Procedure: surgery of zone II cut flexor repair |
| repair using Walant | Other | Surgery repair zone II under WALANT Receives: Procedure: surgery of zone II cut flexor repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motions using Jamar finger goniometer
The functions of treated fingers were calculated using original Strickland and Glogovac criteria
Measured: baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .)
Secondary outcomes (3)
complications
as adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma
Measured: baseline
Healing vs failure of repair
if can move and use flexor tendons again or not
Measured: baseline
DASH score using DASH questionnaire
Disabilites of the Arm , Shoulder , Hand
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Feb 2020
- Primary completion15 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cut Flexor HandStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- repair zone II cut flexor of hand under GA and Walant
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina S. Fekry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089124
- Sponsor's protocol ID
- zone II flexor repair
- Status last verified
- Nov 2021
- First submitted
- 9 Sep 2019
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wolfe SW, Pederson WC, Hotchkiss RN, Kozin SH , Cohen MS. Green's Operative Hand Surgery E-book. Elsevier Health sciences ; 2016 Feb 24.
Canale ST, Beaty JH, Campbell WC. Campbell's operative orthopaedics. 2013.
Lalonde D. Wide Awake Hand Surgery . CRC press. 2016 Jan 27.
Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
PubMed 22431948Farnebo S, Chang J. Practical management of tendon disorders in the hand. Plast Reconstr Surg. 2013 Nov;132(5):841e-853e. doi: 10.1097/PRS.0b013e3182a48ccf.
PubMed 24165636Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.
PubMed 29145985Pires Neto PJ, Moreira LA, Las Casas PP. Is it safe to use local anesthesia with adrenaline in hand surgery? WALANT technique. Rev Bras Ortop. 2017 Jul 19;52(4):383-389. doi: 10.1016/j.rboe.2017.05.006. eCollection 2017 Jun-Jul.
PubMed 28884094Lalonde DH, Kozin S. Tendon disorders of the hand. Plast Reconstr Surg. 2011 Jul;128(1):1e-14e. doi: 10.1097/PRS.0b013e3182174593.
PubMed 21701291Lalonde DH. Latest Advances in Wide Awake Hand Surgery. Hand Clin. 2019 Feb;35(1):1-6. doi: 10.1016/j.hcl.2018.08.002.
PubMed 30470325Higgins A, Lalonde DH, Bell M, McKee D, Lalonde JF. Avoiding flexor tendon repair rupture with intraoperative total active movement examination. Plast Reconstr Surg. 2010 Sep;126(3):941-945. doi: 10.1097/PRS.0b013e3181e60489.
PubMed 20463621Festen-Schrier VJMM, Amadio PC. Wide Awake Surgery as an Opportunity to Enhance Clinical Research. Hand Clin. 2019 Feb;35(1):93-96. doi: 10.1016/j.hcl.2018.08.003.
PubMed 30470336Osada D, Fujita S, Tamai K, Yamaguchi T, Iwamoto A, Saotome K. Flexor tendon repair in zone II with 6-strand techniques and early active mobilization. J Hand Surg Am. 2006 Jul-Aug;31(6):987-92. doi: 10.1016/j.jhsa.2006.03.012.
PubMed 16843161Wong YR, Lee CS, Loke AM, Liu X, Suzana MJ I, Tay SC. Comparison of Flexor Tendon Repair Between 6-Strand Lim-Tsai With 4-Strand Cruciate and Becker Technique. J Hand Surg Am. 2015 Sep;40(9):1806-11. doi: 10.1016/j.jhsa.2015.05.007. Epub 2015 Jun 30.
PubMed 26142080Kleinert HE, Spokevicius S, Papas NH. History of flexor tendon repair. J Hand Surg Am. 1995 May;20(3 Pt 2):S46-52. doi: 10.1016/s0363-5023(95)80169-3. No abstract available.
PubMed 7642949
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare the Outcomes Of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia No Tourniquet
- ClinicalTrials.gov ID
- NCT04089124
- Acronym / sponsor ID
- zone II flexor repair
- Conditions
- Cut Flexor Hand, Walant, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Sep 2019 (actual)
- 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.
Comparison between results of repair of cut flexor zone II under General anesthesia and Walant
Detailed description
Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management \&mobilization to prevent adhesions and improve gliding but risk of rupture.
The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to 14th century (area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery and anesthesia repair is possible with good results.
General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.
WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .
This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.
2)sheath and pulley damage are minimized, as flexor tendons are repaired through small transverse sheathotomy incisions 3) the surgeon can interview the patient during the procedure and assess the ability to comply with the postoperative regimen 4) the risks of general anesthesia are avoided in most patients. Negative effects of general anesthesia include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general anesthesia,and others
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- repair zone II cut flexor of hand under GA and Walant
| Arm | Type | Receives |
|---|---|---|
| repair using General anesthesia ( control group) | Other | Procedure: surgery of zone II cut flexor repairSurgery repair zone II under GA |
| repair using Walant | Other | Procedure: surgery of zone II cut flexor repairSurgery repair zone II under WALANT |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Acute zone II flexor tendon injuries of the hand in both genders in medial four fingers.
- Cooperative patients aged between 16-60 years.
- Sharp mechanism of injury
- Single level injury
Key exclusion criteria (7 listed)
- Age less than sixteen years old or more than sixty years old .
- Associated fractures close to the tendon injury.
- Vascular injury requiring revascularization
- Multiple level injury
- Combined flexor and extensor laceration
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 |
|---|---|---|
| surgery of zone II cut flexor repairwe will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture | Procedure or surgery | repair using General anesthesia ( control group), repair using Walant |
Primary outcome
range of motions using Jamar finger goniometer
Time frame: baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .)
The functions of treated fingers were calculated using original Strickland and Glogovac criteria
3 secondary outcomes
complications
Time frame: baseline
Healing vs failure of repair
Time frame: baseline
DASH score using DASH questionnaire
Time frame: 6 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 30 Nov 2022.
- BackgroundWolfe SW, Pederson WC, Hotchkiss RN, Kozin SH , Cohen MS. Green's Operative Hand Surgery E-book. Elsevier Health sciences ; 2016 Feb 24.
- BackgroundCanale ST, Beaty JH, Campbell WC. Campbell's operative orthopaedics. 2013.
- BackgroundLalonde D. Wide Awake Hand Surgery . CRC press. 2016 Jan 27.
- Background: PubMed 22431948Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
- Background: PubMed 24165636Farnebo S, Chang J. Practical management of tendon disorders in the hand. Plast Reconstr Surg. 2013 Nov;132(5):841e-853e. doi: 10.1097/PRS.0b013e3182a48ccf.
- Background: PubMed 29145985Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.
- Background: PubMed 28884094Pires Neto PJ, Moreira LA, Las Casas PP. Is it safe to use local anesthesia with adrenaline in hand surgery? WALANT technique. Rev Bras Ortop. 2017 Jul 19;52(4):383-389. doi: 10.1016/j.rboe.2017.05.006. eCollection 2017 Jun-Jul.
- Background: PubMed 21701291Lalonde DH, Kozin S. Tendon disorders of the hand. Plast Reconstr Surg. 2011 Jul;128(1):1e-14e. doi: 10.1097/PRS.0b013e3182174593.
- Background: PubMed 30470325Lalonde DH. Latest Advances in Wide Awake Hand Surgery. Hand Clin. 2019 Feb;35(1):1-6. doi: 10.1016/j.hcl.2018.08.002.
- Background: PubMed 20463621Higgins A, Lalonde DH, Bell M, McKee D, Lalonde JF. Avoiding flexor tendon repair rupture with intraoperative total active movement examination. Plast Reconstr Surg. 2010 Sep;126(3):941-945. doi: 10.1097/PRS.0b013e3181e60489.
- Background: PubMed 30470336Festen-Schrier VJMM, Amadio PC. Wide Awake Surgery as an Opportunity to Enhance Clinical Research. Hand Clin. 2019 Feb;35(1):93-96. doi: 10.1016/j.hcl.2018.08.003.
- Background: PubMed 16843161Osada D, Fujita S, Tamai K, Yamaguchi T, Iwamoto A, Saotome K. Flexor tendon repair in zone II with 6-strand techniques and early active mobilization. J Hand Surg Am. 2006 Jul-Aug;31(6):987-92. doi: 10.1016/j.jhsa.2006.03.012.
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?
A study testing surgery of zone II cut flexor repair in people with Cut Flexor Hand and Walant, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 7 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 30 Nov 2022. 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 Egypt. 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?
range of motions using Jamar finger goniometer (time frame: baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04089124, which also lists 14 linked publications.
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 30 Nov 2022.