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NCT07910123

A National, Randomized, Single-blind Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries Compared to the Prosthesis Used in Clinical Practice

Sponsor: ChM sp. z o.o.

View on ClinicalTrials.gov

Summary

The objective of the study is to evaluate the safety and effectiveness of the TMChM tendon prosthesis in the treatment of patients with chronic flexor tendon injuries of the fingers, compared with a reference tendon prosthesis currently used in clinical practice. To achieve this objective, finger flexor tendon function will be assessed before and after implantation of either the TMChM tendon prosthesis or the reference prosthesis in patients with chronic flexor tendon injuries of the fingers. The study is designed to demonstrate that the investigational TMChM tendon prosthesis is non-inferior in terms of effectiveness and safety to the prosthesis currently used in clinical practice. The study aims to answer the following questions: * Does the use of the TMChM finger flexor tendon prosthesis result in non-inferior functional outcomes, as assessed by finger tendon function parameters, in patients with chronic flexor tendon injuries compared with the prosthesis currently used in clinical practice? * Can the TMChM tendon prosthesis be safely implanted using the intended surgical technique? The investigational medical device is the TMChM temporary finger flexor tendon prosthesis. The prosthesis incorporates an attachment for the FDS-FDP loop, enabling functional activation of the prosthesis and maintaining tension in the flexor muscles. Additionally, it allows for shaping of the FDS-FDP connection. The patented TMChM temporary finger flexor tendon prosthesis features an attachment located at the proximal end of its silicone core. The prosthesis attachment has a semicircular cross-section, while the core has rounded sides and a rounded distal end. The TMChM prosthesis is intended for implantation during the first stage of surgical treatment of chronic flexor tendon injuries of the fingers. Furthermore, the TMChM prosthesis contains barium sulfate as a radiopaque marker, allowing it to be visualized during X-ray examinations.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-04-01

Completion Date

2030-03-31

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Tendon Injuries

Interventions

PROCEDURE

Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation

Chronic finger flexor tendon injuries are treated using a two-stage surgical procedure. During the first stage, the temporary tendon prosthesis is implanted to create a tendon sheath tunnel for subsequent grafting. The damaged tendon remnants are removed, and the pulleys and digital nerves are reconstructed if necessary. The prosthesis is secured distally to the FDP stump and proximally to the FDS-FDP tendon loop. Passive rehabilitation begins after wound healing. After approximately 10-12 weeks, the second procedure is performed. The prosthesis is removed and replaced with a tendon graft harvested from the forearm, which is passed through the newly formed tunnel and fixed to the distal phalanx. The procedure concludes with wound closure and immobilization of the wrist and fingers, followed by controlled postoperative rehabilitation.

Inclusion Criteria: 1. Provision of written informed consent to participate in the clinical investigation. 2. Male and female patients aged ≥18 years. 3. Patients with chronic complete rupture of both finger flexor tendons (FDS and FDP): * Confirmed by X-ray examination. * Confirmed by ultrasound examination. 4. Patients with failure of tendon repair (suture dehiscence) and/or tendon adhesions resulting in complete loss of tendon function: * Confirmed by X-ray examination. * Confirmed by ultrasound examination. 5. Patients whose hand has been adequately prepared through rehabilitation, including: * Complete healing of previous fractures and wounds. * Removal of residual suture material. * Restoration of the maximum achievable passive range of motion in the affected joints. 6. Patients who are not eligible for primary tendon repair due to the time elapsed since the finger flexor tendon injury (at least 6 weeks) and the condition of the surrounding tendon tissues. 7. Patients with chronic complete rupture of both finger flexor tendons (FDS and FDP), with an injury duration not exceeding 3 years. Exclusion Criteria: 1. Inadequate condition of the skin and soft tissues at the surgical site that precludes surgical reconstruction. 2. Poor general health status that prevents the patient from undergoing surgical treatment. 3. Active infection at the planned surgical site. 4. Neuromuscular disorders that may pose a high risk of surgical failure or postoperative complications. 5. Suspected or documented allergy or intolerance to the prosthesis material. 6. Inability or unwillingness to comply with the study procedures, postoperative instructions, rehabilitation requirements, or scheduled follow-up visits, as determined by the Investigator. 7. Any condition in which the available finger flexor tendon prosthesis would be too large or too small to achieve a successful treatment outcome. 8. Impaired blood supply or vascular insufficiency in the area intended for implantation of the finger flexor tendon prosthesis. 9. Pregnancy (confirmed by a pregnancy test) or breastfeeding. 10. Hand dysfunction caused by conditions other than chronic finger flexor tendon injuries, such as the absence of a bone segment.

Locations (2)

Clinical Department of Orthopedics and Traumatology of the Movement Organ, Medical University of Gdańsk.

Gdansk, Poland

Department of Plastic Surgery and Hand Surgery, Hospital of Święta Jadwiga Śląska in Trzebnica

Trzebnica, Poland