Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery

NCT05082480 | Terminated

• 1 other identifier: RDCT-TWDH
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

To Evaluate the Effectiveness of the use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery

Conditions

Trigger Finger; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• The percentage of Total Active Motion (TAM) score for target finger.

  The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.

  30 days post-operation

Secondary Outcomes (8)

• The percentage of TAM score of target finger.

  baseline, 14, 60, 90, and 180 days post-operation

• TAM score of target finger.

  baseline, 14, 30, 60, 90, and 180 days post-operation

• The grade of TAM score of target finger and contralateral finger.

  baseline, 14, 30, 60, 90, and 180 days post-operation

• Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.

  baseline, 14, 30, 60, 90, and 180 days post-operation

• Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).

  baseline, 14, 30, 60, 90, and 180 days post-operation

Study Arms (2)

Hyaluronic acid (HA)

EXPERIMENTAL

Hyaluronic acid (HA)

Device: Hyaluronic acid (HA)

Saline

PLACEBO COMPARATOR

Saline

Device: Saline

Interventions

Hyaluronic acid (HA) DEVICE

Hyaluronic acid (HA)

Hyaluronic acid (HA)

Saline DEVICE

Saline

Saline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to participate in this study and sign informed consent form
• Age 20 to 65 years of male or female
• The trigger finger, except thumb, classified as 3 to 4 points and plan to conduct trigger finger release surgery;
• The trigger finger, except thumb, classified as 2 points with the symptom of flexion contracture and plan to conduct trigger finger release surgery;
• Agree to comply with the follow-up schedule of this study

You may not qualify if:

• Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease;
• Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
• Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
• The operation site was conducted tendon transplantation or any surgery in past 6 months;
• Receiving orthopedic-related treatment which may affect the evaluation of the study;
• The skin of the operation site with infection, deficiency, or needing skin transplantation;
• With poorly controlled chronic diseases, such as diabetes mellitus;
• Patient with autoimmune disease (such as rheumatoid arthritis), malignant tumors, coagulation diseases, heart diseases, mental diseases, etc., may cause patients to participate in the trial at higher risk;
• Patient who has taken cortisol within the past 6 months, systemic corticosteroids within the past 2 months, immunosuppressive drugs within past 3 months, or non-steroidal anti-inflammatory drugs (NSAIDs) everyday within 1 week or NSAIDs within 8 hours occasionally. (subjects who have received inhaled/intranasal corticosteroids could be considered to include.);
• With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days;
• With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study;
• Pregnant, planning pregnancy or in breastfeeding females;
• Other circumstances which judged to be unsuitable for participating in the study by the investigator.

Sponsors & Collaborators

• SciVision Biotech Inc.: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: May 5, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: May 12, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)