Flexor Tendon InjuryNCT07596017
Comparing Two Skin Incisions for Flexor Tendon Repair
A study testing Skin incision for flexor tendon repair in people with Flexor Tendon Injury and Incision, Surgical, run by Sahlgrenska University Hospital.
Trial summary
Flexor tendons injuries in the fingers are common and often require surgery. During surgery, the surgeon needs to make an incision in the skin on the inside of the finger to access the damaged tendon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Tendon Injury, Incision, Surgical
- What is being tested?
- Skin incision for flexor tendon repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2028
- 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
- flexor tendon injury in the hand in zone 2
Who cannot join
- complex injuries with fracture and/or skin defect
- previous injury with functional deficit of the finger or the contralateral control finger
- incapable to follow the training protocol for flexor tendon injuries
- not proficient in swedish or english language
- active substance abuse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lena Shafie, MSc contact
About this study
Official title: Prospective Randomized Controlled Trial to Compare Bruner Incision With Modified Midlateral Bruner Incision for Flexor Tendon Repair
Flexor tendons injuries in the fingers are common and often require surgery. During surgery, the surgeon needs to make an incision in the skin on the inside of the finger to access the damaged tendon.
A comparison will be done between two types of skin incisions in the fingers:
Read more
- Bruner zig-zag incision
- modified Bruner midlateral zig-zag incision
Research questions:
- Is there a difference in pain between the types of incisions?
- Is there a difference in swelling between the types of incisions?
- Does the type of incision affect the final result in term of motion?
Patients who will undergo surgery for a flexor tendon injury in a finger will be asked to participate and be randomized to one type of skin incision. All other parts of the surgery will be carried out as usual.
An occupational therapist and nurse will measure swelling and motion. The participant will report pain on a daily basis.
The results for pain, swelling, motion in the fingers and sensibility in the fingers will be statistically compared between the two types of incisions on a group level.
The results of this study may lead to guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the rehabilitation program and improve the final functional outcome.
Read the detailed description
Background and Purpose Tendon injuries are a common type of hand trauma, with flexor tendon injuries most often occurring in zone II. Careful surgical technique followed by early, intensive mobilization under the supervision of a hand therapist is of utmost importance. The traditional Bruner incision, a zig-zag incision, provides wide exposure. However, it also causes extensive soft tissue trauma, leading to swelling and pain, which in turn may reduce adherence to hand rehabilitation protocols. The modified Bruner incision is an alternative approach in which the incision is placed along the lateral side of the finger and slightly curved volarly toward the midpoint between the flexion creases, without crossing the volar midline. This approach provides adequate exposure of the flexor tendon and the digital neurovascular structures with less dissection. Clinical experience suggests that the modified Bruner incision may result in less swelling and pain, faster wound healing and improved conditions for early mobilization. However, there is currently a lack of studies comparing clinical outcomes between the traditional Bruner incision and the modified Bruner incision.
The aim of this study is to investigate whether there are differences in swelling, pain and functional outcomes between patients undergoing flexor tendon repair using the traditional Bruner incision versus the modified Bruner incision.
Research Questions
In primary repair of zone II flexor tendon injuries:
- Do patients treated with a modified Bruner incision experience less postoperative pain during the first three months after surgery?
- Do fingers operated on using a modified Bruner incision demonstrate reduced swelling during the first three postoperative months?
- Do fingers repaired with a modified Bruner incision show improved range of motion during the first three postoperative months?
Methods A randomized controlled study conducted at the Department of Hand Surgery, Mölndal Hospital.
Eligible patients with acute flexor tendon injuries will be invited to participate. After providing informed consent, participants will be randomised to undergo either a standard Bruner incision or a modified midlateral Bruner incision, with all other operative and perioperative variables standardised between the groups.
All procedures will be performed by either a specialist in hand surgery or a hand surgery resident. Within three days postoperatively, at the first dressing change, patients will be assessed by an occupational therapist.
Follow-up evaluations will be conducted at fixed time points: 2, 4, 6, 8, and 12 weeks after surgery. Wound healing will be monitored weekly by a nurse until complete healing has been achieved.
Outcome Measures
Primary outcome
- Pain during exercise, measured using the Visual Analogue Scale (VAS) 0-10; assessed on postoperative day 3 and thereafter daily for 3 months postoperatively (REDCap questionnaire) Secondary outcomes
- Resting pain
- Daily use of analgesics (REDCap questionnaire)
- Swelling: circumference of the injured finger / circumference of the contralateral finger (OT)
- Range of motion: Total Passive Motion (TPM) and Total Active Motion (TAM) of the injured finger / TPM and TAM of the contralateral finger (OT)
- Fingertip sensibility: Semmes-Weinstein monofilament testing (OT), two-point discrimination (physician)
- Extension deficit of the proximal and distal interphalangeal joints (PIP and DIP) (OT)
- Wound healing: Surgical Wound Assessment Tool (SWAT) (nurse)
- Length of the skin incision (cm); a photograph of the incision pattern is obtained intraoperatively
Independent Variables
- Sex
- Age
- Systemic disease: diabetes mellitus, vascular disease, chronic obstructive pulmonary disease (COPD)
- Occupation
- Occupational injury Yes/No
- Mechanism of injury
- Number of injured fingers
- Digital nerve injury
- Type of anesthesia
- Type of suture
- Type of rehabiliation protocol
- Complications: wound infection, suture rupture, conversion of incision
Data Sources Data will be recorded in eCRF using REDCap. Patients will report daily, at predefined time points, VAS pain scores and number of analgesic tablets taken the same day through mobile-based questionaries.
Statistical Analysis The primary outcome measure is pain during exercise, where a between-group difference of 2 points is considered clinically relevant. Assuming a significance level of p < 0.05 and an estimated standard deviation of 2.5 points, the required sample size is calculated to be 26 patients per group to achieve 80% power. To compensate for potential dropouts, a total of 70 patients will be included (35 in each group). Differences in pain, swelling and range of motion at different time points will be compared using bivariate analyses.
Ethics Participation in the study does not involve any change in standard care, except for the surgical incision, which differs between two established methods, the Bruner incision and the modified Bruner incision. Both incision types are standard treatments and have been in clinical use for many years. All patients will receive oral and written information and provide informed consent before inclusion. Participation is voluntary and may be discontinued at any time without affecting the patient's care. Collected data will be pseudonymized and stored securely in locked storage.
Clinical Benefit The results of this study may lead to evidence-based guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the postoperative rehabilitation program and improve the final functional outcome.
- Conditions
- Flexor Tendon Injury, Incision, Surgical
- Being tested
- Skin incision for flexor tendon repair
- Keywords
- incision, Bruner, midlateral incision, flexor tendon, modified Bruner
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin incision for flexor tendon repairProcedure or surgery
Two different types of skin incisions will be compared for patients needing flexor tendon repair in the finger.
| Study group | Role | What they receive |
|---|---|---|
| Bruner | Active comparator | Traditional Bruner skin incision Receives: Procedure: Skin incision for flexor tendon repair |
| Modified Bruner | Active comparator | Modified midlateral Bruner skin incision Receives: Procedure: Skin incision for flexor tendon repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain with exercise
Visual Analogue scale from 0 to 10. 0 = is no pain at all; 10 = the worst pain
Measured: from day 3 after surgery, daily until 3 months after surgery
Secondary outcomes (9)
pain at rest
Visual Analogue Scale from 0 to 10. 0 = no pain at all; 10 = the worst pain
Measured: from day 3 after surgery until 3 months after surgery
pain medication
use of pain medication, opioids/non-opioids
Measured: from day 3 after surgery until 3 months after surgery
swelling
fingers circumferens in mm
Measured: at 2, 4, 6, 8, 12 weeks
range of motion
total active motion of the finger
Measured: at 2, 4, 6, 8, 12 weeks
sensation SW
Semmes-Weinstein in the fingertip
Measured: at 8 weeks
sensation 2PD
two-point discrimination in the fingertip
Measured: at 8 weeks
extension lag
extension lag in the PIP and DIP
Measured: at 2, 4, 6, 8, 12 weeks
skin healing
Healing scored according to the Surgical Wound Assessment Tool leading to a score between 0 and 39. 0 = the best score and 39 the worst.
Measured: at 2, 3, 4, weeks
length of incision
length of incision in cm
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Västra Götalandsregionen, Göteborg University
- Responsible party
- Principal investigator, Anders Bjorkman, Sahlgrenska University Hospital
- Investigators
- Anders Björkman, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596017
- Sponsor's protocol ID
- Dnr 2026-00708-01
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I don't see why this would be necessary and it is probably not allowed by my ethical authority.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Compare Bruner Incision With Modified Midlateral Bruner Incision for Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT07596017
- Acronym / sponsor ID
- Dnr 2026-00708-01
- Conditions
- Flexor Tendon Injury, Incision, Surgical
- Keywords
- incision, Bruner, midlateral incision, flexor tendon, modified Bruner
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Västra Götalandsregionen, Göteborg University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 19 May 2026 (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.
Flexor tendons injuries in the fingers are common and often require surgery. During surgery, the surgeon needs to make an incision in the skin on the inside of the finger to access the damaged tendon.
A comparison will be done between two types of skin incisions in the fingers:
- Bruner zig-zag incision
- modified Bruner midlateral zig-zag incision
Research questions:
- Is there a difference in pain between the types of incisions?
- Is there a difference in swelling between the types of incisions?
- Does the type of incision affect the final result in term of motion?
Patients who will undergo surgery for a flexor tendon injury in a finger will be asked to participate and be randomized to one type of skin incision. All other parts of the surgery will be carried out as usual.
An occupational therapist and nurse will measure swelling and motion. The participant will report pain on a daily basis.
The results for pain, swelling, motion in the fingers and sensibility in the fingers will be statistically compared between the two types of incisions on a group level.
The results of this study may lead to guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the rehabilitation program and improve the final functional outcome.
Detailed description
Background and Purpose Tendon injuries are a common type of hand trauma, with flexor tendon injuries most often occurring in zone II. Careful surgical technique followed by early, intensive mobilization under the supervision of a hand therapist is of utmost importance. The traditional Bruner incision, a zig-zag incision, provides wide exposure. However, it also causes extensive soft tissue trauma, leading to swelling and pain, which in turn may reduce adherence to hand rehabilitation protocols. The modified Bruner incision is an alternative approach in which the incision is placed along the lateral side of the finger and slightly curved volarly toward the midpoint between the flexion creases, without crossing the volar midline. This approach provides adequate exposure of the flexor tendon and the digital neurovascular structures with less dissection. Clinical experience suggests that the modified Bruner incision may result in less swelling and pain, faster wound healing and improved conditions for early mobilization. However, there is currently a lack of studies comparing clinical outcomes between the traditional Bruner incision and the modified Bruner incision.
The aim of this study is to investigate whether there are differences in swelling, pain and functional outcomes between patients undergoing flexor tendon repair using the traditional Bruner incision versus the modified Bruner incision.
Research Questions
In primary repair of zone II flexor tendon injuries:
- Do patients treated with a modified Bruner incision experience less postoperative pain during the first three months after surgery?
- Do fingers operated on using a modified Bruner incision demonstrate reduced swelling during the first three postoperative months?
- Do fingers repaired with a modified Bruner incision show improved range of motion during the first three postoperative months?
Methods A randomized controlled study conducted at the Department of Hand Surgery, Mölndal Hospital.
Eligible patients with acute flexor tendon injuries will be invited to participate. After providing informed consent, participants will be randomised to undergo either a standard Bruner incision or a modified midlateral Bruner incision, with all other operative and perioperative variables standardised between the groups.
All procedures will be performed by either a specialist in hand surgery or a hand surgery resident. Within three days postoperatively, at the first dressing change, patients will be assessed by an occupational therapist.
Follow-up evaluations will be conducted at fixed time points: 2, 4, 6, 8, and 12 weeks after surgery. Wound healing will be monitored weekly by a nurse until complete healing has been achieved.
Outcome Measures
Primary outcome
- Pain during exercise, measured using the Visual Analogue Scale (VAS) 0-10; assessed on postoperative day 3 and thereafter daily for 3 months postoperatively (REDCap questionnaire) Secondary outcomes
- Resting pain
- Daily use of analgesics (REDCap questionnaire)
- Swelling: circumference of the injured finger / circumference of the contralateral finger (OT)
- Range of motion: Total Passive Motion (TPM) and Total Active Motion (TAM) of the injured finger / TPM and TAM of the contralateral finger (OT)
- Fingertip sensibility: Semmes-Weinstein monofilament testing (OT), two-point discrimination (physician)
- Extension deficit of the proximal and distal interphalangeal joints (PIP and DIP) (OT)
- Wound healing: Surgical Wound Assessment Tool (SWAT) (nurse)
- Length of the skin incision (cm); a photograph of the incision pattern is obtained intraoperatively
Independent Variables
- Sex
- Age
- Systemic disease: diabetes mellitus, vascular disease, chronic obstructive pulmonary disease (COPD)
- Occupation
- Occupational injury Yes/No
- Mechanism of injury
- Number of injured fingers
- Digital nerve injury
- Type of anesthesia
- Type of suture
- Type of rehabiliation protocol
- Complications: wound infection, suture rupture, conversion of incision
Data Sources Data will be recorded in eCRF using REDCap. Patients will report daily, at predefined time points, VAS pain scores and number of analgesic tablets taken the same day through mobile-based questionaries.
Statistical Analysis The primary outcome measure is pain during exercise, where a between-group difference of 2 points is considered clinically relevant. Assuming a significance level of p < 0.05 and an estimated standard deviation of 2.5 points, the required sample size is calculated to be 26 patients per group to achieve 80% power. To compensate for potential dropouts, a total of 70 patients will be included (35 in each group). Differences in pain, swelling and range of motion at different time points will be compared using bivariate analyses.
Ethics Participation in the study does not involve any change in standard care, except for the surgical incision, which differs between two established methods, the Bruner incision and the modified Bruner incision. Both incision types are standard treatments and have been in clinical use for many years. All patients will receive oral and written information and provide informed consent before inclusion. Participation is voluntary and may be discontinued at any time without affecting the patient's care. Collected data will be pseudonymized and stored securely in locked storage.
Clinical Benefit The results of this study may lead to evidence-based guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the postoperative rehabilitation program and improve the final functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruner | Active comparator | Procedure: Skin incision for flexor tendon repairTraditional Bruner skin incision |
| Modified Bruner | Active comparator | Procedure: Skin incision for flexor tendon repairModified midlateral Bruner skin incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- flexor tendon injury in the hand in zone 2
Key exclusion criteria (5 listed)
- complex injuries with fracture and/or skin defect
- previous injury with functional deficit of the finger or the contralateral control finger
- incapable to follow the training protocol for flexor tendon injuries
- not proficient in swedish or english language
- active substance abuse
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 |
|---|---|---|
| Skin incision for flexor tendon repairTwo different types of skin incisions will be compared for patients needing flexor tendon repair in the finger. | Procedure or surgery | Bruner, Modified Bruner |
Primary outcome
pain with exercise
Time frame: from day 3 after surgery, daily until 3 months after surgery
Visual Analogue scale from 0 to 10. 0 = is no pain at all; 10 = the worst pain
9 secondary outcomes
pain at rest
Time frame: from day 3 after surgery until 3 months after surgery
pain medication
Time frame: from day 3 after surgery until 3 months after surgery
swelling
Time frame: at 2, 4, 6, 8, 12 weeks
range of motion
Time frame: at 2, 4, 6, 8, 12 weeks
sensation SW
Time frame: at 8 weeks
sensation 2PD
Time frame: at 8 weeks
extension lag
Time frame: at 2, 4, 6, 8, 12 weeks
skin healing
Time frame: at 2, 3, 4, weeks
length of incision
Time frame: at 3 months
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 22 May 2026.
- Individual participant dataSharing planned: Undecided. I don't see why this would be necessary and it is probably not allowed by my ethical authority.
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Virtual Reality Combined With Active Mobilization Post Flexor Tendon Repair
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Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
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Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
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Active, not recruiting
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
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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.
Lena Shafie, MSc contact
Anders Björkman, MD, PhD principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A study testing Skin incision for flexor tendon repair in people with Flexor Tendon Injury and Incision, Surgical, run by Sahlgrenska University Hospital.
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 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: opening soon, as of the sponsor's last update on 22 May 2026. 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 Katleen Libberecht, MD (+46 731471269, katleen.libberecht@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain with exercise (time frame: from day 3 after surgery, daily until 3 months after surgery). 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 May 2026.