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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kai Wang, MD
- Numero di telefono: 86+19821288715
- Email: 2019wk@sjtu.edu.cn
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200233
- Reclutamento
- Shanghai sixth people's hospital
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Contatto:
- Shen Liu, PhD
- Numero di telefono: +86 18930170230
- Email: liushensjtu@sjtu.edu.cn
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
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Nessun intervento: No Postoperative Normal Saline Injection
Participants will undergo flexor tendon repair without postoperative normal saline injections. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Active Motion at 3 Months After Surgery
Lasso di tempo: 3 months after surgery
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Active Motion at 6 Weeks After Surgery
Lasso di tempo: 6 weeks after surgery
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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
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Visual Analog Scale Pain Score
Lasso di tempo: 6 weeks and 3 months after surgery
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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
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Michigan Hand Outcomes Questionnaire Score
Lasso di tempo: 6 weeks and 3 months after surgery
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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
|
Collaboratori e investigatori
Sponsor
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2025-119(1)
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