Injury of Extensor Tendon of HandNCT07335653
Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon Repair of the Hand
A study testing High-Purity Type I Collagen (HPTC) Wrap and Standard Extensor Tendon Repair in people with Injury of Extensor Tendon of Hand and Tendon Adhesions, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites in India.
Trial summary
Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injury of Extensor Tendon of Hand, Tendon Adhesions
- What is being tested?
- High-Purity Type I Collagen (HPTC) Wrap and Standard Extensor Tendon Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIndia
- Study dates
- 5 Dec 2025to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Acute open laceration of extensor tendons in zone VI, VII, or VIII of the hand / wrist (according to Verdan's classification), involving digits 2-5 and/or wrist extensors.
- Complete tendon laceration (≥50% tendon cross-sectional area), requiring primary repair.
- Time from injury to surgical repair ≤72 hours.
- Single upper limb involved.
- Ability and willingness to comply with postoperative rehabilitation protocol and follow-up visits.
- Provision of written informed consent.
Who cannot join
- Crush, avulsion, or segmental tendon loss requiring graft or tendon transfer.
- Associated open fractures requiring dorsal plating across the repair site, or extensive bone loss affecting joint stability.
- Previous surgery or significant scarring over the injured extensor tendon region.
- Associated major nerve injury requiring graft or complex reconstruction (digital nerve repair without grafting may be allowed if balanced between groups).
- Uncontrolled systemic illness (e.g., HbA1c > 8.5% for diabetes, severe peripheral vascular disease, chronic steroid use, severe malnutrition).
- Active infection at the injury site.
Show all 9Show fewer
- Known allergy or hypersensitivity to bovine/ovine collagen or any component of HPTC.
- Pregnancy or lactation.
- Inability to provide informed consent or comply with follow-up.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
About this study
Official title: A Randomized Controlled Trial Evaluating High-Purity Type I Collagen Wrap Around Extensor Tendon Repair Sites in Zones VI-VIII of the Hand to Prevent Adhesions and Improve Functional Outcomes
Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane can reduce adhesion formation and improve functional outcomes compared with standard repair alone.
Read the detailed description
Extensor tendon injuries of the hand are common due to the superficial location of the tendons and the thin soft tissue envelope over the dorsum of the hand and wrist. These injuries, particularly in zones VI-VIII, are frequently associated with postoperative adhesions and extensor lag, leading to functional impairment and delayed return to work. Postsurgical adhesions may occur in up to 30-40% of tendon injuries and remain a major clinical challenge despite advances in suture techniques and rehabilitation protocols.
Several strategies have been investigated to minimize tendon adhesions, including optimized suture techniques, early mobilization, anti-adhesive agents, and biologic barrier membranes. Recent clinical work has shown that wrapping repaired extensor tendons with an amniotic membrane in zone VI can improve range of motion (ROM), Quick DASH scores, and recovery time, suggesting a true reduction in peritendinous fibrosis. Experimental models have also demonstrated that collagen-glycosaminoglycan (GAG) wraps can reduce early postoperative tendon adhesions while preserving tendon healing strength.
HPTC is a bioengineered, acellular dermal replacement product composed of >97% pure Type I collagen, free of elastin, lipids, and immunogenic proteins. It is manufactured to preserve the native triple helical structure and bioactivity of collagen, providing a cell-conducive scaffold that promotes neovascularization, granulation tissue formation, and tissue remodelling. HPTC is flexible, translucent, moderately tacky, and can be cut, sutured or stapled, making it feasible to be fashioned as a wrap or sleeve around tendons.
Multiple randomized controlled trials and clinical series by Narayan et al. have demonstrated the safety and efficacy of high-purity Type I collagen-based skin substitute HPTC in chronic and acute wounds.
These studies collectively show that high-purity Type I collagen membranes are safe, well tolerated, promote faster wound healing, and have favourable scarring and pain profiles in a variety of clinical settings.
Rationale for the Current Study - Given the strong biological plausibility of Type I collagen scaffolds as biocompatible, resorbable barriers that can modulate the healing milieu; the safety and clinical efficacy of HPTC in multiple wound types; and the demonstrated benefit of biologic wraps (e.g., amniotic membrane) around extensor tendon repairs in reducing adhesions, it is logical to evaluate whether a HPTC wrap around the repaired extensor tendon in zones VI-VIII can reduce adhesion-related stiffness and improve functional outcomes compared with standard repair alone.
This trial will be, to our knowledge, the first prospective randomized clinical trial to assess HPTC as a tendon wrap in extensor tendon repairs of the hand.
- Being tested
- High-Purity Type I Collagen (HPTC) Wrap, Standard Extensor Tendon Repair
- Keywords
- Extensor tendon repair, Tendon adhesion, High Purity Type I Collagen, Biologic wrap, Hand injuries
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Purity Type I Collagen (HPTC) WrapDevice
After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.
Standard Extensor Tendon RepairProcedure or surgery
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
| Study group | Role | What they receive |
|---|---|---|
| HPTC Wrap + Standard Extensor Tendon Repair | Active comparator | After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions. Receives: Device: High-Purity Type I Collagen (HPTC) Wrap; Procedure: Standard Extensor Tendon Repair |
| Standard Extensor Tendon Repair Alone | Other | Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. Receives: Procedure: Standard Extensor Tendon Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion (TAM) of Involved Finger(s)
Total Active Motion (TAM) is calculated as the sum of active flexion at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints minus the extension deficits. TAM is expressed in degrees. Higher values indicate better functional outcome.
Measured: 8 weeks postoperatively
Secondary outcomes (6)
QuickDASH Score
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire assessing upper limb disability and symptoms. Lower scores indicate better function. Higher scores indicate greater impairment. Score Range 0 to 100.
Measured: 6 weeks and 8 weeks postoperatively
Extensor Lag
Extensor lag was calculated as the total extension deficit (in degrees) across the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints of the involved finger(s). The deficits at each joint were summed to generate a single total extensor lag value. Lower values indicate better functional outcome.
Measured: 8 weeks postoperatively
Number of Participants With Clinically Significant Tendon Adhesions
Number of participants who developed clinically significant tendon adhesions within 8 weeks postoperatively. Clinically significant adhesion was defined as failure to achieve Total Active Motion (TAM) ≥60% of the contralateral digit despite adherence to rehabilitation protocol and/or requirement for surgical tenolysis. Higher values indicate greater frequency of adhesion-related complications.
Measured: Up to 8 weeks postoperatively
Grip Strength
Grip strength measured using a calibrated Jamar dynamometer and expressed as a percentage of the contralateral uninvolved side. Higher values indicate better functional recovery.
Measured: 8 weeks postoperatively
Time to Return to Work or Activities of Daily Living
Number of days from surgery to return to pre-injury occupational or activities of daily living status.
Measured: Up to 8 weeks postoperatively
Patient Satisfaction
Patient-reported satisfaction with hand function and appearance measured using Likert scale. Scale range: 1 to 10 (1 = very dissatisfied, 10 = very satisfied). Interpretation: Higher scores indicate greater patient satisfaction.
Measured: 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start5 Dec 2025
- Primary completion21 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Injury of Extensor Tendon of HandStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Sponsor type
- University, hospital or other
- Collaborators
- Mysore Medical College and Research Institute
- Responsible party
- Sponsor
- Investigators
- Prema Dhanraj, MS, MCh, Study chair, Rajarajeshwari Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335653
- Sponsor's protocol ID
- AIMS/IEC/270/2025
- Status last verified
- Mar 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be shared. This includes demographic variables, injury characteristics, intervention allocation, Total Active Motion (TAM) measurements, QuickDASH scores, extensor lag measurements, grip strength values, complication data, and time-to-return-to-work variables. Data dictionaries and metadata necessary to interpret the shared datasets will also be provided.
Publications
15. Wong JKF, Metcalfe AD, Wong R, Bush J, Platt C, McGrouther DA. Reduction of tendon adhesion formation with a collagen-GAG scaffold: an experimental study. J Hand Surg Eur Vol. 2006;31(2):143-150.
Moran SL, Ryan CK, Orlando GS, Ehara K, Hentz VR. Effects of anti-adhesion barriers on the healing of repaired extensor digitorum communis tendons in a rabbit model. J Hand Surg Am. 2000;25(3):546-553.
Narayan N, Raghupathi D, Ramamurthy V, Chethan S, Gowda S. A Comparative Analysis in the Treatment of Full-Thickness Wounds: Negative-Pressure Wound Therapy (NPWT) Combined With High-Purity Type I Collagen-Based Skin Substitute Versus NPWT Alone. Cureus. 2025 Nov 16;17(11):e96977. doi: 10.7759/cureus.96977. eCollection 2025 Nov.
PubMed 41250786Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.
PubMed 41122365Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.
PubMed 40862036Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
PubMed 40747200Wong JK, Lui YH, Kapacee Z, Kadler KE, Ferguson MW, McGrouther DA. The cellular biology of flexor tendon adhesion formation: an old problem in a new paradigm. Am J Pathol. 2009 Nov;175(5):1938-51. doi: 10.2353/ajpath.2009.090380. Epub 2009 Oct 15.
PubMed 19834058Al-Qattan MM. Controlled active motion following extensor tendon repair in zones V-VIII. J Hand Surg Br. 2005;30(2):166-169.
VERDAN CE. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960 Jun;42-A:647-57. No abstract available.
PubMed 13855215Newport ML, Blair WF, Steyers CM Jr. Long-term results of extensor tendon repair. J Hand Surg Am. 1990 Nov;15(6):961-6. doi: 10.1016/0363-5023(90)90024-l.
PubMed 2269792
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating High-Purity Type I Collagen Wrap Around Extensor Tendon Repair Sites in Zones VI-VIII of the Hand to Prevent Adhesions and Improve Functional Outcomes
- ClinicalTrials.gov ID
- NCT07335653
- Acronym / sponsor ID
- AIMS/IEC/270/2025
- Keywords
- Extensor tendon repair, Tendon adhesion, High Purity Type I Collagen, Biologic wrap, Hand injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G NagaraUniversity, hospital or other
- Collaborators
- Mysore Medical College and Research Institute
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 21 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane can reduce adhesion formation and improve functional outcomes compared with standard repair alone.
Detailed description
Extensor tendon injuries of the hand are common due to the superficial location of the tendons and the thin soft tissue envelope over the dorsum of the hand and wrist. These injuries, particularly in zones VI-VIII, are frequently associated with postoperative adhesions and extensor lag, leading to functional impairment and delayed return to work. Postsurgical adhesions may occur in up to 30-40% of tendon injuries and remain a major clinical challenge despite advances in suture techniques and rehabilitation protocols.
Several strategies have been investigated to minimize tendon adhesions, including optimized suture techniques, early mobilization, anti-adhesive agents, and biologic barrier membranes. Recent clinical work has shown that wrapping repaired extensor tendons with an amniotic membrane in zone VI can improve range of motion (ROM), Quick DASH scores, and recovery time, suggesting a true reduction in peritendinous fibrosis. Experimental models have also demonstrated that collagen-glycosaminoglycan (GAG) wraps can reduce early postoperative tendon adhesions while preserving tendon healing strength.
HPTC is a bioengineered, acellular dermal replacement product composed of >97% pure Type I collagen, free of elastin, lipids, and immunogenic proteins. It is manufactured to preserve the native triple helical structure and bioactivity of collagen, providing a cell-conducive scaffold that promotes neovascularization, granulation tissue formation, and tissue remodelling. HPTC is flexible, translucent, moderately tacky, and can be cut, sutured or stapled, making it feasible to be fashioned as a wrap or sleeve around tendons.
Multiple randomized controlled trials and clinical series by Narayan et al. have demonstrated the safety and efficacy of high-purity Type I collagen-based skin substitute HPTC in chronic and acute wounds.
These studies collectively show that high-purity Type I collagen membranes are safe, well tolerated, promote faster wound healing, and have favourable scarring and pain profiles in a variety of clinical settings.
Rationale for the Current Study - Given the strong biological plausibility of Type I collagen scaffolds as biocompatible, resorbable barriers that can modulate the healing milieu; the safety and clinical efficacy of HPTC in multiple wound types; and the demonstrated benefit of biologic wraps (e.g., amniotic membrane) around extensor tendon repairs in reducing adhesions, it is logical to evaluate whether a HPTC wrap around the repaired extensor tendon in zones VI-VIII can reduce adhesion-related stiffness and improve functional outcomes compared with standard repair alone.
This trial will be, to our knowledge, the first prospective randomized clinical trial to assess HPTC as a tendon wrap in extensor tendon repairs of the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPTC Wrap + Standard Extensor Tendon Repair | Active comparator | Device: High-Purity Type I Collagen (HPTC) Wrap, Procedure: Standard Extensor Tendon RepairAfter completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions. |
| Standard Extensor Tendon Repair Alone | Other | Procedure: Standard Extensor Tendon RepairPrimary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65 years.
- Acute open laceration of extensor tendons in zone VI, VII, or VIII of the hand / wrist (according to Verdan's classification), involving digits 2-5 and/or wrist extensors.
- Complete tendon laceration (≥50% tendon cross-sectional area), requiring primary repair.
- Time from injury to surgical repair ≤72 hours.
- Single upper limb involved.
Key exclusion criteria (9 listed)
- Crush, avulsion, or segmental tendon loss requiring graft or tendon transfer.
- Associated open fractures requiring dorsal plating across the repair site, or extensive bone loss affecting joint stability.
- Previous surgery or significant scarring over the injured extensor tendon region.
- Associated major nerve injury requiring graft or complex reconstruction (digital nerve repair without grafting may be allowed if balanced between groups).
- Uncontrolled systemic illness (e.g., HbA1c > 8.5% for diabetes, severe peripheral vascular disease, chronic steroid use, severe malnutrition).
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 |
|---|---|---|
| High-Purity Type I Collagen (HPTC) WrapAfter completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions. | Device | HPTC Wrap + Standard Extensor Tendon Repair |
| Standard Extensor Tendon RepairPrimary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct. | Procedure or surgery | HPTC Wrap + Standard Extensor Tendon Repair, Standard Extensor Tendon Repair Alone |
Primary outcome
Total Active Motion (TAM) of Involved Finger(s)
Time frame: 8 weeks postoperatively
Total Active Motion (TAM) is calculated as the sum of active flexion at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints minus the extension deficits. TAM is expressed in degrees. Higher values indicate better functional outcome.
6 secondary outcomes
QuickDASH Score
Time frame: 6 weeks and 8 weeks postoperatively
Extensor Lag
Time frame: 8 weeks postoperatively
Number of Participants With Clinically Significant Tendon Adhesions
Time frame: Up to 8 weeks postoperatively
Grip Strength
Time frame: 8 weeks postoperatively
Time to Return to Work or Activities of Daily Living
Time frame: Up to 8 weeks postoperatively
Patient Satisfaction
Time frame: 8 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background15. Wong JKF, Metcalfe AD, Wong R, Bush J, Platt C, McGrouther DA. Reduction of tendon adhesion formation with a collagen-GAG scaffold: an experimental study. J Hand Surg Eur Vol. 2006;31(2):143-150.
- BackgroundMoran SL, Ryan CK, Orlando GS, Ehara K, Hentz VR. Effects of anti-adhesion barriers on the healing of repaired extensor digitorum communis tendons in a rabbit model. J Hand Surg Am. 2000;25(3):546-553.
- Background: PubMed 41250786Narayan N, Raghupathi D, Ramamurthy V, Chethan S, Gowda S. A Comparative Analysis in the Treatment of Full-Thickness Wounds: Negative-Pressure Wound Therapy (NPWT) Combined With High-Purity Type I Collagen-Based Skin Substitute Versus NPWT Alone. Cureus. 2025 Nov 16;17(11):e96977. doi: 10.7759/cureus.96977. eCollection 2025 Nov.
- Background: PubMed 41122365Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.
- Background: PubMed 40862036Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.
- Background: PubMed 40747200Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
- Background: PubMed 19834058Wong JK, Lui YH, Kapacee Z, Kadler KE, Ferguson MW, McGrouther DA. The cellular biology of flexor tendon adhesion formation: an old problem in a new paradigm. Am J Pathol. 2009 Nov;175(5):1938-51. doi: 10.2353/ajpath.2009.090380. Epub 2009 Oct 15.
- BackgroundAl-Qattan MM. Controlled active motion following extensor tendon repair in zones V-VIII. J Hand Surg Br. 2005;30(2):166-169.
- Background: PubMed 13855215VERDAN CE. Primary repair of flexor tendons. J Bone Joint Surg Am. 1960 Jun;42-A:647-57. No abstract available.
- Background: PubMed 2269792Newport ML, Blair WF, Steyers CM Jr. Long-term results of extensor tendon repair. J Hand Surg Am. 1990 Nov;15(6):961-6. doi: 10.1016/0363-5023(90)90024-l.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the primary and secondary outcome analyses will be shared. This includes demographic variables, injury characteristics, intervention allocation, Total Active Motion (TAM) measurements, QuickDASH scores, extensor lag measurements, grip strength values, complication data, and time-to-return-to-work variables. Data dictionaries and metadata necessary to interpret the shared datasets will also be provided.
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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. This study is not recruiting at the moment.
Prema Dhanraj, MS, MCh study chair
Rajarajeshwari Medical College and Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Purity Type I Collagen (HPTC) Wrap and Standard Extensor Tendon Repair in people with Injury of Extensor Tendon of Hand and Tendon Adhesions, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites in India.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 13 Apr 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 India. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Active Motion (TAM) of Involved Finger(s) (time frame: 8 weeks postoperatively). 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 NCT07335653, which also lists 10 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 13 Apr 2026.