Tendon Injury - HandNCT03135340
Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Flexor Tendon Repair
A study testing WALANT, General/regional anesthesia and WALANT Injection in people with Tendon Injury - Hand, run by University of Western Ontario, Canada.
Trial summary
Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a block, unable to perform motor function in the arm, and with patient either intubated or sedated, unable to follow surgeon instructions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- WALANT, General/regional anesthesia and WALANT Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Nov 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- over the age of 18
- acute single or multiple digit complete flexor tendon lacerations in zones I or II presenting to attending physicians who agree to participate in the study.
Who cannot join
- gross wound contamination
- segmental tendon loss
- associated finger fractures
- sub-acute or chronic ruptures (ruptures > 6 weeks old)
- active or previous infection in the wound bed
- requirement of delayed repair
Show all 11Show fewer
- complex or multisystem injuries
- multiple digit injuries
- significant joint injuries
- amputations (replants)
- mangled hand injuries.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Hand Flexor Tendon Repair in Zones I and II: a Prospective Randomized Controlled Trial
Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a block, unable to perform motor function in the arm, and with patient either intubated or sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a wide awake and cooperative patient is routinely performed successfully at some centres. This method provides several potential benefits including being able to have the patient actively flex the digit and visualize the repair site to assess for any tendon gapping at the repair site, ensure adequate approximation, gliding and absence of triggering. There have not been any prospectively collected randomized controlled trials comparing wide awake vs. regional/general anesthesia in flexor tendon repair. The purpose of our study is to assess for differences in early outcomes including stiffness, patient satisfaction and early complications in wide-awake anesthesia when compared to general/regional anesthesia for flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication rate and better outcomes when using wide-awake flexor tendon repair.
Read the detailed description
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bowstringing and quadrigia.
Wide-awake flexor tendon repair using local anesthesia and epinephrine with no tourniquet has been described. Safety of epinephrine in digits makes it possible, and epinephrine-induced vasoconstriction precludes the need for a tourniquet and cautery.This approach allows a wide-awake, comfortable, non-sedated, cooperative, tourniquet-free patient to test the freshly repaired tendon with full active range of motion intraoperatively. The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures, revise pulley reconstruction, or de-bulk tendons before wound closure. This could mean that a higher quality repair is possible and could guide post-operative rehabilitation. It follows that if the patient is unable to achieve total active range of motion intraoperatively they will not be able to postoperatively and may end up requiring a tenolysis. Lalonde and colleagues looked retrospectively at their 15 years of experience using WALANT with the hypothesis that this technique decreased their post-operative rupture rate. With 122 patients there were only 3 ruptures, all due to unexpected forceful movements. Contraindications of this technique include patients who are unable or unwilling to tolerate an operation while awake, pediatric patients, those who are mentally impaired, and complex trauma.
Improved compliance with postoperative therapy is also reported after patients visualize the repair in real time and gain a better understanding of limitations and expectations. Patient buy-in to the rehabilitation process is potentially improved if the surgeon can use the operative time to educate the patient, show them the repair, and manage expectations since the patient is wide-awake and coherent. Wide-awake flexor tendon repair could also improve surgeon confidence in initiating a true active motion therapy protocol when the surgeon visualizes the absence of gapping with full finger flexion. Initiation of early active motion could subsequently improve ultimate post-operative range of motion and patient satisfaction. The advent of wide-awake flexor tendon repair could have economic implications as well given that fewer resources are theoretically used for the procedure.
Currently there are no prospective randomized controlled studies evaluating outcomes in flexor tendon repairs that have utilized a wide-awake anaesthesia protocol and comparing outcomes with traditional repair techniques.
The purpose of this study is to evaluate and compare outcomes of WALANT (wide-awake, local anesthetic, no tourniquet) when compared to traditional general/regional anesthetic for flexor tendon repairs in zone I and II.
- Conditions
- Tendon Injury - Hand
- Being tested
- WALANT, General/regional anesthesia, WALANT Injection, Regional Anesthetic Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALANTProcedure or surgery
These patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine.
General/regional anesthesiaProcedure or surgery
These patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol.
WALANT InjectionDrug
1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.
Regional Anesthetic InjectionDrug
0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.
| Study group | Role | What they receive |
|---|---|---|
| WALANT | Experimental | These patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine. Receives: Procedure: WALANT; Drug: WALANT Injection |
| General/regional anesthesia | Active comparator | These patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol. Receives: Procedure: General/regional anesthesia; Drug: Regional Anesthetic Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
Measured: 1 year
Secondary outcomes (7)
Total active range of motion
This is measured as active digit motion measured at the proximal interphalangeal and distal interphalangeal joints with use of a goniometer by a hand therapist
Measured: 1 year
Strickland Criteria Score
The sum of active ranges of motion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints. Then the percentage is calculated, in comparison to the contralateral side. The scores are then recorded as one of four categories: Excellent: 85-100%, Good: 70-84%, Fair: 50-69, Poor: 0-49%
Measured: 1 year
Pain of procedure by visual analogue scale (VAS)
Measured on visual analogue scale on a 10cm line and scored out of 10 (0 being no pain and 10 being maximum pain)
Measured: 1 week
Pain of procedure by pain diary
The pain diary is used by the patient at home to record subjective daily pain from 0-10 at a predetermined time every day.
Measured: 1 week
Subjective anxiety
anxiety surrounding procedure as measured on a VAS (from 0 being no anxiety to 10 being maximum anxiety)
Measured: 1 week
Repeat procedure question
The patient is asked whether or not they would undergo the procedure the same way again (yes or no).
Measured: 1 week
DASH (disabilities of the arm, shoulder and hand) Score
This outcome instrument is a thirty-question self-reported survey of function and symptoms in patients with upper extremity disorders. Scores range from 0 (no disability) to 100 (completely disabled).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study startAug 2017 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tendon Injury - HandStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups. One interventional group and one control group with random allocation as described below.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruby Grewal, MD MSc FRCSC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135340
- Sponsor's protocol ID
- UWO7788705772
- Status last verified
- Apr 2017
- First submitted
- 6 Dec 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verdan CE. Half a century of flexor-tendon surgery. Current status and changing philosophies. J Bone Joint Surg Am. 1972 Apr;54(3):472-91. No abstract available.
PubMed 4560071Saldana MJ, Chow JA, Gerbino P 2nd, Westerbeck P, Schacherer TG. Further experience in rehabilitation of zone II flexor tendon repair with dynamic traction splinting. Plast Reconstr Surg. 1991 Mar;87(3):543-6. doi: 10.1097/00006534-199103000-00023.
PubMed 1998024Lilly SI, Messer TM. Complications after treatment of flexor tendon injuries. J Am Acad Orthop Surg. 2006 Jul;14(7):387-96. doi: 10.5435/00124635-200607000-00001.
PubMed 16822886Wilhelmi BJ, Blackwell SJ, Miller J, Mancoll JS, Phillips LG. Epinephrine in digital blocks: revisited. Ann Plast Surg. 1998 Oct;41(4):410-4. doi: 10.1097/00000637-199810000-00010.
PubMed 9788222Denkler K. A comprehensive review of epinephrine in the finger: to do or not to do. Plast Reconstr Surg. 2001 Jul;108(1):114-24. doi: 10.1097/00006534-200107000-00017.
PubMed 11420511Nodwell T, Lalonde D. How long does it take phentolamine to reverse adrenaline-induced vasoconstriction in the finger and hand? A prospective, randomized, blinded study: The Dalhousie project experimental phase. Can J Plast Surg. 2003 Winter;11(4):187-90. doi: 10.1177/229255030301100408.
PubMed 24009436Higgins 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 20463621Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg. 2009 Feb;123(2):623-625. doi: 10.1097/PRS.0b013e318195664c. No abstract available.
PubMed 19182622Lalonde DH. An evidence-based approach to flexor tendon laceration repair. Plast Reconstr Surg. 2011 Feb;127(2):885-890. doi: 10.1097/PRS.0b013e31820467b6.
PubMed 21285792Momeni A, Grauel E, Chang J. Complications after flexor tendon injuries. Hand Clin. 2010 May;26(2):179-89. doi: 10.1016/j.hcl.2009.11.004.
PubMed 20494744Dowd MB, Figus A, Harris SB, Southgate CM, Foster AJ, Elliot D. The results of immediate re-repair of zone 1 and 2 primary flexor tendon repairs which rupture. J Hand Surg Br. 2006 Oct;31(5):507-13. doi: 10.1016/j.jhsb.2006.06.006. Epub 2006 Aug 22.
PubMed 16930791Mustoe TA, Buck DW 2nd, Lalonde DH. The safe management of anesthesia, sedation, and pain in plastic surgery. Plast Reconstr Surg. 2010 Oct;126(4):165e-176e. doi: 10.1097/PRS.0b013e3181ebe5e9.
PubMed 20885206Strickland JW. Results of flexor tendon surgery in zone II. Hand Clin. 1985 Feb;1(1):167-79.
PubMed 4093459
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wide-Awake Local Anesthesia vs. Regional/General Anesthesia for Hand Flexor Tendon Repair in Zones I and II: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03135340
- Acronym / sponsor ID
- UWO7788705772
- Conditions
- Tendon Injury - Hand
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2033 (estimated)
- First posted
- 1 May 2017 (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.
Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a block, unable to perform motor function in the arm, and with patient either intubated or sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a wide awake and cooperative patient is routinely performed successfully at some centres. This method provides several potential benefits including being able to have the patient actively flex the digit and visualize the repair site to assess for any tendon gapping at the repair site, ensure adequate approximation, gliding and absence of triggering. There have not been any prospectively collected randomized controlled trials comparing wide awake vs. regional/general anesthesia in flexor tendon repair. The purpose of our study is to assess for differences in early outcomes including stiffness, patient satisfaction and early complications in wide-awake anesthesia when compared to general/regional anesthesia for flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication rate and better outcomes when using wide-awake flexor tendon repair.
Detailed description
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bowstringing and quadrigia.
Wide-awake flexor tendon repair using local anesthesia and epinephrine with no tourniquet has been described. Safety of epinephrine in digits makes it possible, and epinephrine-induced vasoconstriction precludes the need for a tourniquet and cautery.This approach allows a wide-awake, comfortable, non-sedated, cooperative, tourniquet-free patient to test the freshly repaired tendon with full active range of motion intraoperatively. The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures, revise pulley reconstruction, or de-bulk tendons before wound closure. This could mean that a higher quality repair is possible and could guide post-operative rehabilitation. It follows that if the patient is unable to achieve total active range of motion intraoperatively they will not be able to postoperatively and may end up requiring a tenolysis. Lalonde and colleagues looked retrospectively at their 15 years of experience using WALANT with the hypothesis that this technique decreased their post-operative rupture rate. With 122 patients there were only 3 ruptures, all due to unexpected forceful movements. Contraindications of this technique include patients who are unable or unwilling to tolerate an operation while awake, pediatric patients, those who are mentally impaired, and complex trauma.
Improved compliance with postoperative therapy is also reported after patients visualize the repair in real time and gain a better understanding of limitations and expectations. Patient buy-in to the rehabilitation process is potentially improved if the surgeon can use the operative time to educate the patient, show them the repair, and manage expectations since the patient is wide-awake and coherent. Wide-awake flexor tendon repair could also improve surgeon confidence in initiating a true active motion therapy protocol when the surgeon visualizes the absence of gapping with full finger flexion. Initiation of early active motion could subsequently improve ultimate post-operative range of motion and patient satisfaction. The advent of wide-awake flexor tendon repair could have economic implications as well given that fewer resources are theoretically used for the procedure.
Currently there are no prospective randomized controlled studies evaluating outcomes in flexor tendon repairs that have utilized a wide-awake anaesthesia protocol and comparing outcomes with traditional repair techniques.
The purpose of this study is to evaluate and compare outcomes of WALANT (wide-awake, local anesthetic, no tourniquet) when compared to traditional general/regional anesthetic for flexor tendon repairs in zone I and II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups. One interventional group and one control group with random allocation as described below.
| Arm | Type | Receives |
|---|---|---|
| WALANT | Experimental | Procedure: WALANT, Drug: WALANT InjectionThese patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine. |
| General/regional anesthesia | Active comparator | Procedure: General/regional anesthesia, Drug: Regional Anesthetic InjectionThese patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over the age of 18
- acute single or multiple digit complete flexor tendon lacerations in zones I or II presenting to attending physicians who agree to participate in the study.
Key exclusion criteria (11 listed)
- gross wound contamination
- segmental tendon loss
- associated finger fractures
- sub-acute or chronic ruptures (ruptures > 6 weeks old)
- active or previous infection in the wound bed
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 |
|---|---|---|
| WALANTThese patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine. | Procedure or surgery | WALANT |
| General/regional anesthesiaThese patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol. | Procedure or surgery | General/regional anesthesia |
| WALANT Injection1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots. | Drug | WALANT |
| Regional Anesthetic Injection0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots. | Drug | General/regional anesthesia |
Primary outcome
Complication rate
Time frame: 1 year
Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
7 secondary outcomes
Total active range of motion
Time frame: 1 year
Strickland Criteria Score
Time frame: 1 year
Pain of procedure by visual analogue scale (VAS)
Time frame: 1 week
Pain of procedure by pain diary
Time frame: 1 week
Subjective anxiety
Time frame: 1 week
Repeat procedure question
Time frame: 1 week
DASH (disabilities of the arm, shoulder and hand) Score
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Background: PubMed 4560071Verdan CE. Half a century of flexor-tendon surgery. Current status and changing philosophies. J Bone Joint Surg Am. 1972 Apr;54(3):472-91. No abstract available.
- Background: PubMed 1998024Saldana MJ, Chow JA, Gerbino P 2nd, Westerbeck P, Schacherer TG. Further experience in rehabilitation of zone II flexor tendon repair with dynamic traction splinting. Plast Reconstr Surg. 1991 Mar;87(3):543-6. doi: 10.1097/00006534-199103000-00023.
- Background: PubMed 16822886Lilly SI, Messer TM. Complications after treatment of flexor tendon injuries. J Am Acad Orthop Surg. 2006 Jul;14(7):387-96. doi: 10.5435/00124635-200607000-00001.
- Background: PubMed 9788222Wilhelmi BJ, Blackwell SJ, Miller J, Mancoll JS, Phillips LG. Epinephrine in digital blocks: revisited. Ann Plast Surg. 1998 Oct;41(4):410-4. doi: 10.1097/00000637-199810000-00010.
- Background: PubMed 11420511Denkler K. A comprehensive review of epinephrine in the finger: to do or not to do. Plast Reconstr Surg. 2001 Jul;108(1):114-24. doi: 10.1097/00006534-200107000-00017.
- Background: PubMed 24009436Nodwell T, Lalonde D. How long does it take phentolamine to reverse adrenaline-induced vasoconstriction in the finger and hand? A prospective, randomized, blinded study: The Dalhousie project experimental phase. Can J Plast Surg. 2003 Winter;11(4):187-90. doi: 10.1177/229255030301100408.
- 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 19182622Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg. 2009 Feb;123(2):623-625. doi: 10.1097/PRS.0b013e318195664c. No abstract available.
- Background: PubMed 21285792Lalonde DH. An evidence-based approach to flexor tendon laceration repair. Plast Reconstr Surg. 2011 Feb;127(2):885-890. doi: 10.1097/PRS.0b013e31820467b6.
- Background: PubMed 20494744Momeni A, Grauel E, Chang J. Complications after flexor tendon injuries. Hand Clin. 2010 May;26(2):179-89. doi: 10.1016/j.hcl.2009.11.004.
- Background: PubMed 16930791Dowd MB, Figus A, Harris SB, Southgate CM, Foster AJ, Elliot D. The results of immediate re-repair of zone 1 and 2 primary flexor tendon repairs which rupture. J Hand Surg Br. 2006 Oct;31(5):507-13. doi: 10.1016/j.jhsb.2006.06.006. Epub 2006 Aug 22.
- Background: PubMed 20885206Mustoe TA, Buck DW 2nd, Lalonde DH. The safe management of anesthesia, sedation, and pain in plastic surgery. Plast Reconstr Surg. 2010 Oct;126(4):165e-176e. doi: 10.1097/PRS.0b013e3181ebe5e9.
- Individual participant dataSharing planned: No
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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.
Ruby Grewal, MD MSc FRCSC principal investigator
Western University, Canada
Questions about this trial
What is this clinical trial studying?
A study testing WALANT, General/regional anesthesia and WALANT Injection in people with Tendon Injury - Hand, run by University of Western Ontario, Canada.
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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruby Grewal, MD MSc FRCSC (519-646-6286, rgrew@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 1 year). 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 NCT03135340, which also lists 13 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 17 Jul 2017.