Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Kai Wang, MD
- Telefonnummer: 86+19821288715
- E-Mail: 2019wk@sjtu.edu.cn
Studienorte
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200233
- Rekrutierung
- Shanghai sixth people's hospital
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Kontakt:
- Shen Liu, PhD
- Telefonnummer: +86 18930170230
- E-Mail: liushensjtu@sjtu.edu.cn
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 18 to 60 years.
- Zone II flexor tendon rupture in the index, middle, ring, or little finger.
- Scheduled to undergo tendon repair surgery.
Exclusion Criteria:
- 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.
- History of rheumatic or autoimmune disease.
- History of chemotherapy or radiotherapy.
- History of steroid treatment.
- Pregnancy.
- Concurrent participation in another clinical trial.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Ultrasound-Guided Repeated Normal Saline Injections
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. |
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. |
|
Kein Eingriff: No Postoperative Normal Saline Injection
Participants will undergo flexor tendon repair without postoperative normal saline injections. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total Active Motion at 3 Months After Surgery
Zeitfenster: 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 months after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total Active Motion at 6 Weeks After Surgery
Zeitfenster: 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. |
6 weeks after surgery
|
|
Visual Analog Scale Pain Score
Zeitfenster: 6 weeks and 3 months after surgery
|
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. |
6 weeks and 3 months after surgery
|
|
Michigan Hand Outcomes Questionnaire Score
Zeitfenster: 6 weeks and 3 months after surgery
|
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. |
6 weeks and 3 months after surgery
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2025-119(1)
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