An interventional study of Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation in Tendon Injuries, sponsored by ChM sp. z o.o.. Not yet recruiting at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by ChM sp. z o.o. · Not applicable, Interventional, and Treatment
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:
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.
100 studies on the registry are indexed under Tendon Injuries; 27 are open to participants now.
This study's planned enrollment of 86 is above the median of 44 across 70 interventional studies indexed under Tendon Injuries.
Browse Tendon Injuries studies →This is the only study on the registry with ChM sp. z o.o. as lead sponsor.
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Patients with chronic complete rupture of both finger flexor tendons (FDS and FDP):
Patients with failure of tendon repair (suture dehiscence) and/or tendon adhesions resulting in complete loss of tendon function:
Patients whose hand has been adequately prepared through rehabilitation, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation
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.
Recovery of finger flexor tendon function
Finger flexor tendon function is assessed with the Buck-Gramcko Scoring System (0-15 points; higher scores indicate better function). A goniometer and ruler are used to evaluate three components: (1) Total active motion (TAM), calculated as the sum of active flexion at the metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints minus their extension deficits: \>159°=6, 141-159°=4, 120-140°=2, \<120°=0 points. (2) Fingertip-to-distal-palmar-crease distance during maximal active flexion: \<2.5 cm=6, 2.5-\<4 cm=4, 4-6 cm=2, \>6 cm=0 points. (3) Total active extension deficit across MCP, PIP and DIP joints: 0-30°=3, 31-50°=2, 51-70°=1, \>70°=0 points. Component scores are summed (0-15): excellent=14-15, good=11-13, fair=7-10, poor=0-6. The total score is compared between TMChM and reference-prosthesis groups; the target difference is 1.5 points in favor of TMChM.
Time frame: From enrollment to the end of treatment at 12 months
Finger Range of Motion
Assessment of the total active flexion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints, corrected for extension deficits, using the Modified Strickland method. The expected improvement is 10 ± 5% following treatment with the TMChM prosthesis and its dedicated surgical technique compared with the reference prosthesis.
Time frame: From enrollment to the end of treatment at 12 months
Grip and Pinch Strength
Assessment of overall hand grip strength and pinch strength using a Jamar hydraulic dynamometer. The expected improvement is 10 ± 5% in the TMChM group compared with the reference prosthesis group.
Time frame: From enrollment to the end of treatment at 12 months
Two-Point Discrimination
Assessment of tactile sensitivity using the Dellon two-point discriminator. The expected outcome is a reduction of 3 ± 1 mm in the minimum distance between two distinguishable points in the TMChM group compared with the reference prosthesis group.
Time frame: From enrollment to the end of treatment at 12 months
Upper Extremity Function
Hand function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, a validated 30-item patient-reported outcome measure evaluating upper limb function, limitations in daily activities, and symptoms, including pain. Each item is rated on a 5-point scale (1-5). Responses are converted into a total DASH score ranging from 0 to 100 points, where 0 indicates no disability and 100 indicates the most severe disability. Higher scores reflect worse upper limb function and greater symptom burden. A decrease in the DASH score indicates clinical improvement. The study aims to demonstrate a 10±5% improvement in hand function and reduction in pain-related symptoms in patients treated with the investigational TMChM prosthesis compared with those treated with the reference prosthesis.
Time frame: From enrollment to the end of treatment at 12 months
Pain Intensity
Hand pain intensity is assessed using the Visual Analogue Scale (VAS), a patient-reported measure of subjective pain intensity. Patients indicate their perceived pain level on a 10-cm scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable or unbearable pain. Scores of 1-3 indicate mild pain, 4-6 moderate pain, and 7-10 severe to unbearable pain. Higher scores indicate greater pain intensity and a worse clinical outcome, while lower scores indicate less pain and a better outcome. A decrease in the VAS score reflects improvement in pain symptoms. The study aims to demonstrate a 10±5% reduction in hand pain intensity following treatment with the investigational TMChM temporary flexor tendon prosthesis compared with the reference prosthesis.
Time frame: From enrollment to the end of treatment at 12 months
Plan to share: Undecided — The clinical investigation is conducted by a commercial sponsor and concerns a medical device owned by the sponsor. The sponsor has not yet decided whether the study results will be published in scientific journals.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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