Trial · NCT07910123
Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
NCT07910123, Not applicable, Not yet recruiting, ChM sp. z o.o.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries. Trials, record NCT07910123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
- NCT number
- NCT07910123
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 86 participants, estimated
- Lead sponsor
- ChM sp. z o.o.
- Conditions
- Tendon Injuries
- Interventions
- Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation
- First posted
- 2026-11-02
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recovery of finger flexor tendon function | From enrollment to the end of treatment at 12 months | 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. |
| Secondary | Finger Range of Motion | From enrollment to the end of treatment at 12 months | 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. |
| Secondary | Grip and Pinch Strength | From enrollment to the end of treatment at 12 months | 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. |
| Secondary | Two-Point Discrimination | From enrollment to the end of treatment at 12 months | 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. |
| Secondary | Upper Extremity Function | From enrollment to the end of treatment at 12 months | 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. |
| Secondary | Pain Intensity | From enrollment to the end of treatment at 12 months | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers24
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910123
GET https://conductscience.org/api/trials/v1/NCT07910123/papers?page=2