An interventional study of High-Purity Type I Collagen (HPTC) Wrap and Standard Extensor Tendon Repair in Injury of Extensor Tendon of Hand and Tendon Adhesions, sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. Completed at 2 sites in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara · Not applicable, Interventional, and Treatment
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.
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.
108 studies on the registry are indexed under Hand Injuries; 31 are open to participants now.
This study's enrollment of 60 is close to the median of 56 across 84 interventional studies indexed under Hand Injuries.
Browse Hand Injuries studies →Adichunchanagiri Institute of Medical Sciences, B G Nagara is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: High-Purity Type I Collagen (HPTC) Wrap · Procedure: Standard Extensor Tendon Repair
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
Procedure: Standard Extensor Tendon Repair
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.
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
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.
Time frame: 8 weeks postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks postoperatively
| Milestone | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
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.
| degrees | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Total Active Motion (TAM) of Involved Finger(s) | 232.4 ± 21.6 | 201.3 ± 26.8 |
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.
| score on a scale | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| At 6 weeks | 24.5 ± 7.8 | 39.8 ± 9.1 |
| At 8 weeks | 18.2 ± 6.9 | 32.6 ± 8.4 |
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.
| degrees | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Extensor Lag | 6.4 ± 4.2 | 15.7 ± 6.1 |
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.
| Participants | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Number of Participants With Clinically Significant Tendon Adhesions | 2 | 9 |
Grip strength measured using a calibrated Jamar dynamometer and expressed as a percentage of the contralateral uninvolved side. Higher values indicate better functional recovery.
| percentage of contralateral side | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Grip Strength | 78.6 ± 9.4 | 63.2 ± 11.1 |
Number of days from surgery to return to pre-injury occupational or activities of daily living status.
| weeks | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Time to Return to Work or Activities of Daily Living | 5.6 ± 1.4 | 7.9 ± 1.8 |
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.
| score on a scale | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Patient Satisfaction | 8.9 ± 0.8 | 7.1 ± 1.2 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HPTC Wrap + Standard Extensor Tendon Repair | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Standard Extensor Tendon Repair Alone | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) |
| Event | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone |
|---|---|---|
| Surgical site infectionSurgical and medical procedures | 0/30 | 1/30 |
| Age, Categorical(Participants) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 30 | 60 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| Mean | 36.9 ± 11.2 | 37.6 ± 10.8 | 37.3 ± 10.9 |
| Sex: Female, Male(Participants) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 21 | 20 | 41 |
| Race/Ethnicity, Customized(Participants) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| Asian (Indian) | 30 | 30 | 60 |
| Region of Enrollment(Participants) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| India | 30 | 30 | 60 |
| Injury Zone(Participants) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| Zone VI | 14 | 15 | 29 |
| Zone VII | 10 | 9 | 19 |
| Zone VIII | 6 | 6 | 12 |
| Injury Complexity(Participants) | HPTC Wrap + Standard Extensor Tendon Repair | Standard Extensor Tendon Repair Alone | Total |
|---|---|---|---|
| Single tendon injury | 19 | 18 | 37 |
| Multiple tendon injuries | 11 | 12 | 23 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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Adichunchanagiri Institute of Medical Sciences, B G Nagara