Tendon InjuriesTMChMNCT07910123
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
A study testing Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation in people with Tendon Injuries, run by ChM sp. z o.o. at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Apr 2027to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent to participate in the clinical investigation.
- Male and female patients aged ≥18 years.
- Patients with chronic complete rupture of both finger flexor tendons (FDS and FDP):
- Confirmed by X-ray examination.
- Confirmed by ultrasound examination.
- Patients with failure of tendon repair (suture dehiscence) and/or tendon adhesions resulting in complete loss of tendon function:
Show all 14Show fewer
- Confirmed by X-ray examination.
- Confirmed by ultrasound examination.
- 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.
- 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.
- Patients with chronic complete rupture of both finger flexor tendons (FDS and FDP), with an injury duration not exceeding 3 years.
Who cannot join
- Inadequate condition of the skin and soft tissues at the surgical site that precludes surgical reconstruction.
- Poor general health status that prevents the patient from undergoing surgical treatment.
- Active infection at the planned surgical site.
- Neuromuscular disorders that may pose a high risk of surgical failure or postoperative complications.
- Suspected or documented allergy or intolerance to the prosthesis material.
- Inability or unwillingness to comply with the study procedures, postoperative instructions, rehabilitation requirements, or scheduled follow-up visits, as determined by the Investigator.
Show all 10Show fewer
- Any condition in which the available finger flexor tendon prosthesis would be too large or too small to achieve a successful treatment outcome.
- Impaired blood supply or vascular insufficiency in the area intended for implantation of the finger flexor tendon prosthesis.
- Pregnancy (confirmed by a pregnancy test) or breastfeeding.
- Hand dysfunction caused by conditions other than chronic finger flexor tendon injuries, such as the absence of a bone segment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Clinical Department of Orthopedics and Traumatology of the Movement Organ, Medical University of Gdańsk.
Gdansk, 80-803
Tomasz Mazurek, Prof. DsC. MD, +48 58 76 40 210, mazurek@gumed.edu.pl
Tomasz Mazurek, Prof. DsC. MD
Department of Plastic Surgery and Hand Surgery, Hospital of Święta Jadwiga Śląska in Trzebnica
Trzebnica, 55-100
Ahmed Elsaftawy, PhD. MD, +48 71 312 09 20, elsaftawyahmed@gmail.com
Ahmed Elsaftawy, PhD. MD
About this study
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.
Read more
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.
- Conditions
- Tendon Injuries
- Being tested
- Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation
- Keywords
- chronic tendon injury, TMChM tendon prosthesis, temporary finger flexor tendon prosthesis
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| The group treated using the investigational TMChM tendon prosthesis | Experimental | Not described Receives: Procedure: Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation |
| The group treated using the comparator tendon prosthesis. | Active comparator | Not described Receives: Procedure: Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of finger flexor tendon function
Recovery of finger flexor tendon function will be assessed using the Buck-Gramcko scoring system, which classifies outcomes into four categories based on scores obtained in three parameters: Total Active Motion (TAM), extension deficit, and fingertip-to-palm distance. This method is consistent with the recommendations of the Tendon Injuries Committee established at the 1983 Hand Surgery Congress in Boston. To demonstrate the non-inferiority of the TMChM tendon prosthesis compared with the standard prosthesis used in clinical practice, postoperative tendon function will be evaluated in both treatment groups using the Buck-Gramcko scale. The study aims to demonstrate a 1.5-point improvement in the Buck-Gramcko score following treatment with the TMChM prosthesis and its dedicated surgical technique compared with the standard prosthesis and corresponding surgical technique.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 months
Upper Extremity Function
Assessment of upper extremity disability and symptoms using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The expected improvement is a 10 ± 5% reduction in the DASH score in the TMChM group compared with the reference prosthesis group, indicating improved function and reduced symptoms.
Measured: From enrollment to the end of treatment at 12 months
Pain Intensity
Assessment of hand pain intensity using the Visual Analogue Scale (VAS). The expected outcome is a 10 ± 5% reduction in pain intensity in the TMChM group compared with the reference prosthesis group.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChM sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Team Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Tomasz Mazurek, Prof. DsC. MD, Principal investigator, Medical University of Gdańsk, Department of Orthopedics and Traumatology of the Movement Organ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910123
- Sponsor's protocol ID
- CHM-TMChM-001
- Acronym
- TMChM
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
PubMed 22431948Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
PubMed 15866967Poggetti A, Novi M, Rosati M, Ciclamini D, Scaglione M, Battiston B. Treatment of flexor tendon reconstruction failures: multicentric experience with Brunelli active tendon implant. Eur J Orthop Surg Traumatol. 2018 Jul;28(5):877-883. doi: 10.1007/s00590-017-2102-x. Epub 2017 Dec 7.
PubMed 29218649Hunter JM, Jaeger SH. Tendon implants: primary and secondary usage. Orthop Clin North Am. 1977 Apr;8(2):473-89.
PubMed 142944Ketchum LD. Twenty-five-year follow-up evaluation of an active silicone/Dacron tendon interposition prosthesis: A case report. J Hand Surg Am. 2000 Jul;25(4):731-3. doi: 10.1053/jhsu.2000.8644.
PubMed 10913215Paneva-Holevich E. Two-stage reconstruction of the flexor tendons. Int Orthop. 1982;6(2):133-8. doi: 10.1007/BF00268657.
PubMed 7152747Beris AE, Darlis NA, Korompilias AV, Vekris MD, Mitsionis GI, Soucacos PN. Two-stage flexor tendon reconstruction in zone II using a silicone rod and a pedicled intrasynovial graft. J Hand Surg Am. 2003 Jul;28(4):652-60. doi: 10.1016/s0363-5023(03)00146-1.
PubMed 12877856Chamay A. [The history of flexor tendon surgery]. Ann Chir Main Memb Super. 1997;16(1):9-15. doi: 10.1016/s0753-9053(97)80013-0. French.
PubMed 9131943Hunter JM. Staged flexor tendon reconstruction. J Hand Surg Am. 1983 Sep;8(5 Pt 2):789-93. doi: 10.1016/s0363-5023(83)80274-3. No abstract available.
PubMed 6630959Battiston B, Triolo PF, Bernardi A, Artiaco S, Tos P. Secondary repair of flexor tendon injuries. Injury. 2013 Mar;44(3):340-5. doi: 10.1016/j.injury.2013.01.023. Epub 2013 Jan 21.
PubMed 23347767Langer MF, Wieskotter B, Herrmann K, Oeckenpohler S. [Flexor tendon transplantation]. Orthopade. 2015 Oct;44(10):777-85. doi: 10.1007/s00132-015-3156-2. German.
PubMed 26399731O'Shea K, Wolfe SW. Two-stage reconstruction with the modified Paneva-Holevich technique. Hand Clin. 2013 May;29(2):223-33. doi: 10.1016/j.hcl.2013.02.011. Epub 2013 Apr 6.
PubMed 23660058Abdul-Kader MH, Amin MA. Two-stage reconstruction for flexor tendon injuries in zone II using a silicone rod and pedicled sublimis tendon graft. Indian J Plast Surg. 2010 Jan;43(1):14-20. doi: 10.1055/s-0039-1699397.
PubMed 20924443Darlis NA, Beris AE, Korompilias AV, Vekris MD, Mitsionis GI, Soucacos PN. Two-stage flexor tendon reconstruction in zone 2 of the hand in children. J Pediatr Orthop. 2005 May-Jun;25(3):382-6. doi: 10.1097/01.bpo.0000152939.28413.a2.
PubMed 15832160Viegas SF. A new modification of two-stage flexor tendon reconstruction. Tech Hand Up Extrem Surg. 2006 Sep;10(3):177-80. doi: 10.1097/01.bth.0000232868.82782.ff.
PubMed 16974224
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07910123
- Acronym / sponsor ID
- TMChM / CHM-TMChM-001
- Conditions
- Tendon Injuries
- Keywords
- chronic tendon injury, TMChM tendon prosthesis, temporary finger flexor tendon prosthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- ChM sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- CTC Team Sp. z o.o.
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group treated using the investigational TMChM tendon prosthesis | Experimental | Procedure: Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation |
| The group treated using the comparator tendon prosthesis. | Active comparator | Procedure: Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of written informed consent to participate in the clinical investigation.
- Male and female patients aged ≥18 years.
- 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:
Key exclusion criteria (10 listed)
- Inadequate condition of the skin and soft tissues at the surgical site that precludes surgical reconstruction.
- Poor general health status that prevents the patient from undergoing surgical treatment.
- Active infection at the planned surgical site.
- Neuromuscular disorders that may pose a high risk of surgical failure or postoperative complications.
- Suspected or documented allergy or intolerance to the prosthesis material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis ImplantationChronic 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. | Procedure or surgery | The group treated using the comparator tendon prosthesis., The group treated using the investigational TMChM tendon prosthesis |
Primary outcome
Recovery of finger flexor tendon function
Time frame: From enrollment to the end of treatment at 12 months
Recovery of finger flexor tendon function will be assessed using the Buck-Gramcko scoring system, which classifies outcomes into four categories based on scores obtained in three parameters: Total Active Motion (TAM), extension deficit, and fingertip-to-palm distance. This method is consistent with the recommendations of the Tendon Injuries Committee established at the 1983 Hand Surgery Congress in Boston. To demonstrate the non-inferiority of the TMChM tendon prosthesis compared with the standard prosthesis used in clinical practice, postoperative tendon function will be evaluated in both treatment groups using the Buck-Gramcko scale. The study aims to demonstrate a 1.5-point improvement in the Buck-Gramcko score following treatment with the TMChM prosthesis and its dedicated surgical technique compared with the standard prosthesis and corresponding surgical technique.
5 secondary outcomes
Finger Range of Motion
Time frame: From enrollment to the end of treatment at 12 months
Grip and Pinch Strength
Time frame: From enrollment to the end of treatment at 12 months
Two-Point Discrimination
Time frame: From enrollment to the end of treatment at 12 months
Upper Extremity Function
Time frame: From enrollment to the end of treatment at 12 months
Pain Intensity
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 22431948Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
- Background: PubMed 15866967Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
- Background: PubMed 29218649Poggetti A, Novi M, Rosati M, Ciclamini D, Scaglione M, Battiston B. Treatment of flexor tendon reconstruction failures: multicentric experience with Brunelli active tendon implant. Eur J Orthop Surg Traumatol. 2018 Jul;28(5):877-883. doi: 10.1007/s00590-017-2102-x. Epub 2017 Dec 7.
- Background: PubMed 142944Hunter JM, Jaeger SH. Tendon implants: primary and secondary usage. Orthop Clin North Am. 1977 Apr;8(2):473-89.
- Background: PubMed 10913215Ketchum LD. Twenty-five-year follow-up evaluation of an active silicone/Dacron tendon interposition prosthesis: A case report. J Hand Surg Am. 2000 Jul;25(4):731-3. doi: 10.1053/jhsu.2000.8644.
- Background: PubMed 7152747Paneva-Holevich E. Two-stage reconstruction of the flexor tendons. Int Orthop. 1982;6(2):133-8. doi: 10.1007/BF00268657.
- Background: PubMed 12877856Beris AE, Darlis NA, Korompilias AV, Vekris MD, Mitsionis GI, Soucacos PN. Two-stage flexor tendon reconstruction in zone II using a silicone rod and a pedicled intrasynovial graft. J Hand Surg Am. 2003 Jul;28(4):652-60. doi: 10.1016/s0363-5023(03)00146-1.
- Background: PubMed 9131943Chamay A. [The history of flexor tendon surgery]. Ann Chir Main Memb Super. 1997;16(1):9-15. doi: 10.1016/s0753-9053(97)80013-0. French.
- Background: PubMed 6630959Hunter JM. Staged flexor tendon reconstruction. J Hand Surg Am. 1983 Sep;8(5 Pt 2):789-93. doi: 10.1016/s0363-5023(83)80274-3. No abstract available.
- Background: PubMed 23347767Battiston B, Triolo PF, Bernardi A, Artiaco S, Tos P. Secondary repair of flexor tendon injuries. Injury. 2013 Mar;44(3):340-5. doi: 10.1016/j.injury.2013.01.023. Epub 2013 Jan 21.
- Background: PubMed 26399731Langer MF, Wieskotter B, Herrmann K, Oeckenpohler S. [Flexor tendon transplantation]. Orthopade. 2015 Oct;44(10):777-85. doi: 10.1007/s00132-015-3156-2. German.
- Background: PubMed 23660058O'Shea K, Wolfe SW. Two-stage reconstruction with the modified Paneva-Holevich technique. Hand Clin. 2013 May;29(2):223-33. doi: 10.1016/j.hcl.2013.02.011. Epub 2013 Apr 6.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomasz Mazurek, Prof. DsC. MD principal investigator
Medical University of Gdańsk, Department of Orthopedics and Traumatology of the Movement Organ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation in people with Tendon Injuries, run by ChM sp. z o.o. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Małkowski, PhD (+48 85 8686 309, andrzej.malkowski@chm.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of finger flexor tendon function (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910123, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.