Tendon AdhesionNCT07861568
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
A study testing Ultrasound-Guided Repeated Normal Saline Injections in people with Tendon Adhesion and Zone II Flexor Tendon Injury, run by Kai Wang at 1 site in China.
Trial summary
Scar tissue can form around a repaired tendon and restrict finger movement. This study will evaluate whether repeated ultrasound-guided normal saline injections, in addition to standard postoperative rehabilitation, can help prevent and treat tendon adhesion after surgical repair of zone II flexor tendon injuries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tendon Adhesion, Zone II Flexor Tendon Injury
- What is being tested?
- Ultrasound-Guided Repeated Normal Saline Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Sep 2027
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years.
- Zone II flexor tendon rupture in the index, middle, ring, or little finger.
- Scheduled to undergo tendon repair surgery.
Who cannot join
- Concomitant irreparable vascular and/or nerve injury.
- History of diabetes mellitus.
- History of treatment with nonsteroidal anti-inflammatory drugs.
- History of cardiac insufficiency.
- History of hematologic disease.
- History of hepatic or renal dysfunction.
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- History of rheumatic or autoimmune disease.
- History of chemotherapy or radiotherapy.
- History of steroid treatment.
- Pregnancy.
- Concurrent participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai sixth people's hospital
Shanghai, Shanghai Municipality, 200233
Shen Liu, PhD, +86 18930170230, liushensjtu@sjtu.edu.cn
About this study
Official title: A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion
Scar tissue can form around a repaired tendon and restrict finger movement. This study will evaluate whether repeated ultrasound-guided normal saline injections, in addition to standard postoperative rehabilitation, can help prevent and treat tendon adhesion after surgical repair of zone II flexor tendon injuries.
The study is a prospective, single-center, randomized controlled trial involving 80 adults aged 18 to 60 years with a zone II flexor tendon rupture in the index, middle, ring, or little finger. Participants will be assigned to one of two groups, with 40 participants in each group. Participants in both groups will receive the same standard postoperative rehabilitation treatment, including early active finger mobilization. In addition to this rehabilitation, the experimental group will receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the tendon adhesion site on postoperative days 7, 14, and 21. The control group will receive standard postoperative rehabilitation alone, without postoperative normal saline injections.
The primary outcome is total active motion of the repaired finger at 3 months after surgery. Finger movement, pain, hand function, postoperative finger infection, and tendon rupture will also be assessed at the scheduled follow-up visits.
Read the detailed description
This prospective, single-center, randomized controlled trial will be conducted at Shanghai Sixth People's Hospital to evaluate the effectiveness and safety of repeated ultrasound-guided normal saline injections as an adjunct to standard postoperative rehabilitation for preventing and treating tendon adhesion after flexor tendon repair.
A total of 80 participants aged 18 to 60 years with a zone II flexor tendon rupture in the index, middle, ring, or little finger who are scheduled to undergo tendon repair will be enrolled. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Participants in both groups will undergo tendon repair and receive the same standard postoperative rehabilitation treatment, including early active finger mobilization. In addition to standard rehabilitation, participants in the experimental group will receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the identified tendon adhesion site on postoperative days 7, 14, and 21. Dynamic ultrasound imaging will be used to observe the distribution of normal saline in the tendon repair region. Participants in the control group will receive standard postoperative rehabilitation alone, without postoperative normal saline injections.
Follow-up assessments will be performed at 6 weeks and 3 months after surgery. The primary outcome is total active motion (TAM) at 3 months after surgery, expressed in degrees and analyzed as a continuous variable. Secondary outcomes include TAM at 6 weeks and visual analog scale (VAS) pain scores, Michigan Hand Outcomes Questionnaire (MHQ) scores, postoperative finger infection rates, and tendon rupture rates at 6 weeks and 3 months.
Safety assessments will include physical examination, vital signs, complete blood count, C-reactive protein, and erythrocyte sedimentation rate. Adverse events will be recorded and evaluated throughout the study.
- Conditions
- Tendon Adhesion, Zone II Flexor Tendon Injury
- Being tested
- Ultrasound-Guided Repeated Normal Saline Injections
- Keywords
- Tendon adhesion, Flexor tendon repair, Zone II flexor tendon injury, Ultrasound guidance, Normal saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Repeated Normal Saline InjectionsProcedure or surgery
Normal saline will be administered by ultrasound-guided percutaneous injection at the identified tendon adhesion site after flexor tendon repair. Each injection will contain 1 mL of normal saline. Injections will be performed on postoperative days 7, 14, and 21.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Repeated Normal Saline Injections | Experimental | Participants will undergo flexor tendon repair and receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the identified tendon adhesion site on postoperative days 7, 14, and 21. Receives: Procedure: Ultrasound-Guided Repeated Normal Saline Injections |
| No Postoperative Normal Saline Injection | No intervention | Participants will undergo flexor tendon repair without postoperative normal saline injections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion at 3 Months After Surgery
Total active motion (TAM) of the surgically repaired finger, expressed in degrees and analyzed as a continuous measure of joint motion.
Measured: 3 months after surgery
Secondary outcomes (3)
Total Active Motion at 6 Weeks After Surgery
Total active motion (TAM) of the surgically repaired finger, expressed in degrees and analyzed as a continuous measure of joint motion.
Measured: 6 weeks after surgery
Visual Analog Scale Pain Score
Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity and a worse outcome.
Measured: 6 weeks and 3 months after surgery
Michigan Hand Outcomes Questionnaire Score
Hand function will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The overall score ranges from 0 to 100, with higher scores indicating better hand function and a better outcome.
Measured: 6 weeks and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon AdhesionStudies 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
- Participants will be randomly assigned in a 1:1 ratio to receive repeated ultrasound-guided postoperative normal saline injections or no postoperative normal saline injections. The planned enrollment is 40 participants per group.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Wang, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861568
- Sponsor's protocol ID
- 2025-119(1)
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion
- ClinicalTrials.gov ID
- NCT07861568
- Acronym / sponsor ID
- 2025-119(1)
- Conditions
- Tendon Adhesion, Zone II Flexor Tendon Injury
- Keywords
- Tendon adhesion, Flexor tendon repair, Zone II flexor tendon injury, Ultrasound guidance, Normal saline injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kai WangUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Oct 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.
Scar tissue can form around a repaired tendon and restrict finger movement. This study will evaluate whether repeated ultrasound-guided normal saline injections, in addition to standard postoperative rehabilitation, can help prevent and treat tendon adhesion after surgical repair of zone II flexor tendon injuries.
The study is a prospective, single-center, randomized controlled trial involving 80 adults aged 18 to 60 years with a zone II flexor tendon rupture in the index, middle, ring, or little finger. Participants will be assigned to one of two groups, with 40 participants in each group. Participants in both groups will receive the same standard postoperative rehabilitation treatment, including early active finger mobilization. In addition to this rehabilitation, the experimental group will receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the tendon adhesion site on postoperative days 7, 14, and 21. The control group will receive standard postoperative rehabilitation alone, without postoperative normal saline injections.
The primary outcome is total active motion of the repaired finger at 3 months after surgery. Finger movement, pain, hand function, postoperative finger infection, and tendon rupture will also be assessed at the scheduled follow-up visits.
Detailed description
This prospective, single-center, randomized controlled trial will be conducted at Shanghai Sixth People's Hospital to evaluate the effectiveness and safety of repeated ultrasound-guided normal saline injections as an adjunct to standard postoperative rehabilitation for preventing and treating tendon adhesion after flexor tendon repair.
A total of 80 participants aged 18 to 60 years with a zone II flexor tendon rupture in the index, middle, ring, or little finger who are scheduled to undergo tendon repair will be enrolled. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Participants in both groups will undergo tendon repair and receive the same standard postoperative rehabilitation treatment, including early active finger mobilization. In addition to standard rehabilitation, participants in the experimental group will receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the identified tendon adhesion site on postoperative days 7, 14, and 21. Dynamic ultrasound imaging will be used to observe the distribution of normal saline in the tendon repair region. Participants in the control group will receive standard postoperative rehabilitation alone, without postoperative normal saline injections.
Follow-up assessments will be performed at 6 weeks and 3 months after surgery. The primary outcome is total active motion (TAM) at 3 months after surgery, expressed in degrees and analyzed as a continuous variable. Secondary outcomes include TAM at 6 weeks and visual analog scale (VAS) pain scores, Michigan Hand Outcomes Questionnaire (MHQ) scores, postoperative finger infection rates, and tendon rupture rates at 6 weeks and 3 months.
Safety assessments will include physical examination, vital signs, complete blood count, C-reactive protein, and erythrocyte sedimentation rate. Adverse events will be recorded and evaluated throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive repeated ultrasound-guided postoperative normal saline injections or no postoperative normal saline injections. The planned enrollment is 40 participants per group.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Repeated Normal Saline Injections | Experimental | Procedure: Ultrasound-Guided Repeated Normal Saline InjectionsParticipants will undergo flexor tendon repair and receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the identified tendon adhesion site on postoperative days 7, 14, and 21. |
| No Postoperative Normal Saline Injection | No intervention | –Participants will undergo flexor tendon repair without postoperative normal saline injections. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 60 years.
- Zone II flexor tendon rupture in the index, middle, ring, or little finger.
- Scheduled to undergo tendon repair surgery.
Key exclusion criteria (11 listed)
- Concomitant irreparable vascular and/or nerve injury.
- History of diabetes mellitus.
- History of treatment with nonsteroidal anti-inflammatory drugs.
- History of cardiac insufficiency.
- History of hematologic disease.
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 |
|---|---|---|
| Ultrasound-Guided Repeated Normal Saline InjectionsNormal saline will be administered by ultrasound-guided percutaneous injection at the identified tendon adhesion site after flexor tendon repair. Each injection will contain 1 mL of normal saline. Injections will be performed on postoperative days 7, 14, and 21. | Procedure or surgery | Ultrasound-Guided Repeated Normal Saline Injections |
Primary outcome
Total Active Motion at 3 Months After Surgery
Time frame: 3 months after surgery
Total active motion (TAM) of the surgically repaired finger, expressed in degrees and analyzed as a continuous measure of joint motion.
3 secondary outcomes
Total Active Motion at 6 Weeks After Surgery
Time frame: 6 weeks after surgery
Visual Analog Scale Pain Score
Time frame: 6 weeks and 3 months after surgery
Michigan Hand Outcomes Questionnaire Score
Time frame: 6 weeks and 3 months after surgery
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 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Tendon Adhesion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Repeated Normal Saline Injections in people with Tendon Adhesion and Zone II Flexor Tendon Injury, run by Kai Wang 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 3 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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?
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 Kai Wang, MD (86+19821288715, 2019wk@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Active Motion at 3 Months After Surgery (time frame: 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 20 Oct 2026.