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Achilles Tendon RuptureNCT07130357

The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

A study testing Collagen Scaffold and Achilles tendon repair in people with Achilles Tendon Rupture, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective multicenter randomized controlled trial evaluates the clinical efficacy of collagen scaffold augmentation in surgical repair for acute Achilles tendon ruptures. The study will enroll 48 adult participants randomly assigned to either the intervention group (surgical repair with collagen scaffold… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Achilles Tendon Rupture
What is being tested?
Collagen Scaffold and Achilles tendon repair
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteHong Kong
Study dates
25 Dec 2025to 31 Dec 2027
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

  • Achilles tendon rupture.
  • Age > 18 and able to provide written informed consent.

Who cannot join

  • Hypersensitive to bovine-derived materials.
  • Prior foot/ankle surgery or intervention within 1 year
  • Ongoing litigation regarding current injury
  • Active psychological or physical condition pre-empting participation, including psychosis, mental retardation, stroke.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samuel K Ling, MBChB (CUHK), ChM (Edin), MRCS contact

+852 3505-2010

samuel.ling@link.cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Shatin, New Territories, 000000

    WENJIE PAN, 852-26364171, wenjiepan@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Prospective Multi-Centre Randomised Controlled Trial on the Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

This prospective multicenter randomized controlled trial evaluates the clinical efficacy of collagen scaffold augmentation in surgical repair for acute Achilles tendon ruptures. The study will enroll 48 adult participants randomly assigned to either the intervention group (surgical repair with collagen scaffold augmentation) or the control group (standard surgical repair without scaffold). The primary outcome is tendon function assessed using the VISA-A score, while secondary outcomes include tendon healing characteristics measured by ultrasound (thickness, neovascularity), calf muscle strength, ankle range of motion, and complication rates. Follow-up assessments will be conducted at 6 weeks, 3 months, 6 months, and 12 months post-surgery. The study aims to determine whether collagen scaffold augmentation enhances tendon healing and functional recovery compared to conventional repair methods, potentially offering a improved treatment approach for Achilles tendon injuries.

Read the detailed description

This study is a prospective multi-center randomized controlled trial investigating the effects of collagen scaffold augmentation in surgical repair of acute Achilles tendon ruptures. The research builds upon existing clinical experience and literature suggesting that while surgical techniques have improved mechanical stability of repaired tendons, biological healing remains a limiting factor in recovery. The trial will compare two treatment approaches: one group will receive standard surgical repair augmented with a collagen scaffold, while the control group will undergo conventional repair without scaffold augmentation.

A total of 48 participants will be recruited from five hospitals and randomly assigned to either group with a 1:1 allocation ratio. The surgical procedure involves end-to-end tendon repair using non-absorbable sutures, with the intervention group additionally receiving a bioinductive collagen scaffold placed over the repair site. All participants will follow the same standardized rehabilitation protocol divided into four phases: protection, early loading, strengthening, and return to function.

Intervention Group:

Participants in the intervention group will undergo Achilles tendon repair with Collagen Scaffold Augmentation.

Upon diagnosis of an Achilles tendon rupture, the participant will receive a temporary slab and surgical repair will be scheduled, and the operation will be performed under general anaesthesia with the patient lying prone. The ruptured ends of the right Achilles tendon will be marked, and a 3 cm longitudinal skin incision will be made along the medial border of the tendon. A standardized end-to-end direct surgical repair using non-absorbable sutures in a 2-strand core in a krackow locking fashion will be performed. The bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors. The surgical site will be closed in layers using 3-0 vicryl and 4-0 ethilon.

The patient will be discharged the following day and will follow a standardized rehabilitation plan by physiotherapist. The rehabilitation is split into 4 phases: the protection phase, early loading phase, strengthening phase and return to function phase. This plan includes non-weight-bearing walking for 2 weeks, partial weight-bearing walking for 4 weeks, then full weight-bearing walking.

Control Group:

Participants in the control group will undergo Achilles tendon repair using the same method as the intervention group, only without the additional collagen scaffold augmentation. The rehabilitation protocol will also be identical to the intervention group.

The primary outcome measure is the Victorian Institute of Sports Assessment-Achilles (VISA-A) score, which evaluates pain, function, and sporting activity. Secondary outcomes include surgical complications, Foot and Ankle Outcome Score (FAOS), ultrasound measurements of tendon thickness and neovascularity, shear wave elastography for tendon elasticity, Achilles tendon resting angle, calf muscle strength, ankle range of motion, and photoacoustic imaging of tendon oxygen saturation. Participants will be assessed at baseline, 6 weeks, 3 months, 6 months, and 12 months post-surgery.

Being tested
Collagen Scaffold, Achilles tendon repair
Keywords
Achilles Tendon Rupture, Collagen Scaffold Augmentation, Regeneten, Achilles Tendon Rupture Repair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collagen ScaffoldDevice

    The bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors.

  • Achilles tendon repairProcedure or surgery

    Upon diagnosis of an Achilles tendon rupture, the participant will receive a temporary slab and surgical repair will be scheduled, and the operation will be performed under general anaesthesia with the patient lying prone. The ruptured ends of the right Achilles tendon will be marked, and a 3 cm longitudinal skin incision will be made along the medial border of the tendon. A standardized end-to-end direct surgical repair using non-absorbable sutures in a 2-strand core in a krackow locking fashion will be performed. The surgical site will be closed in layers using 3-0 vicryl and 4-0 ethilon.

Study groups in NCT07130357
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention group will undergo Achilles tendon repair with Collagen Scaffold Augmentation. Upon diagnosis of an Achilles tendon rupture, the participant will receive a temporary slab and surgical repair will be scheduled, and the operation will be performed under general anaesthesia with the patient lying prone. The ruptured ends of the right Achilles tendon will be marked, and a 3 cm longitudinal skin incision will be made along the medial border of the tendon. A standardized end-to-end direct surgical repair using non-absorbable sutures in a 2-strand core in a krackow locking fashion will be performed. The bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors. The surgical site will be closed in layers using 3-0 vicryl and 4-0 ethilon. The patient will be discharged the following day and will follow a standardized rehabilitation plan by our physiotherapist. The rehabilitation is split into 4 phases: the protect
Receives: Device: Collagen Scaffold; Procedure: Achilles tendon repair
Control GroupActive comparatorParticipants in the control group will undergo Achilles tendon repair using the same method as the intervention group, only without the additional collagen scaffold augmentation. The rehabilitation protocol will also be identical to the intervention group.
Receives: Procedure: Achilles tendon repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Victorian Institute of Sports Assessment (VISA-A)

    The primary outcome is the score of the Victorian Institute of Sports Assessment - Achilles (VISA-A) questionnaire, which is explicitly designed for Achilles tendon. VISA-A will be used to evaluate pain and symptom severity with activity in participants with Achilles tendon rupture. Chinese-speaking participants will complete the validated Chinese VISA-A questionnaire . The VISA-A questionnaire covers three domains associated with AT: pain, function, and sporting activities. A deterioration in self-reported pain, function and sporting activities is the critical reason patients with Achilles tendon rupture come for medical consultation. Improving questions covered in VISA-A is often the rehabilitation goal for these patients.

    Measured: 6 weeks and 3, 6, 12 months after surgery

Secondary outcomes (12)
  1. Surgical complications

    Surgical complications will be recorded, such as would problems and early re-ruptures. Based on current evidence, approximately 1 in 9 patients undergoing operative repair of an acute Achilles tendon rupture developed a postoperative complication.

    Measured: During surgery

  2. Foot and Ankle outcome scores (FAOS)

    The Foot and Ankle Outcome Score (FAOS) is a open-source, validated piece of instrument to evaluate overall foot and ankle function . It is extensively used in foot and ankle clinical research and is calculated using multiple Likert scale questions which are organized into 5 sub-categories: symptoms, pain, activities of daily living (ADL), sports and quality of life (QOL). The answers in each subcategory are then converted into a score from 0 to 100; with 100 resembling no symptoms and 0 resembling severe symptoms.

    Measured: 6 weeks and 3, 6, 12 months

  3. Ultrasound measure of tendon thickness

    B-mode ultrasound will be used to locate and measure the maximum thickness of the Achilles tendon (4-9mm) using a greyscale sonographic image. To minimize anisotropic effect, the transducer will be adjusted to ensure the ultrasound beam is perpendicular to the tendon fibers.

    Measured: 6 weeks and 3, 6. 12 months

  4. Ultrasound measurement of tendon neovascularity

    Doppler mode is used to measure tendon neovascularity. The transducer is placed perpendicular to obtain a sagittal view of the Achilles tendon. The assessor screens the tendon for the area of maximum Doppler flow and takes a sonographic image. The Öhberg score is then determined during the US examination. Scores range from 0 to 3, with a higher score indicating more Doppler flow in the peritendinous and intratendinous tissues. Pressure from the transducer will be kept to a minimum to prevent occlusion of neovascularization

    Measured: 6 weeks and 3, 6 ,12 months

  5. Ultrasound measurement of tendon elasticity

    Shear wave elastography (SWE) is a technique used to quantify the stiffness of soft tissue and provide objective, quantitative data for clinical references. It works by using a focused ultrasound beam to generate shear waves within the tissues, and measuring the velocity of their propagation. To measure the stiffness of a tendon, the optimal scan plane must first be identified, and the SWE function is then activated with a measurable range of stiffness standardized at 0-600 kPa. An electrogram is obtained and stored, and the stiffness of the tendon is measured using a Q-box tool. The Q-box is circular and set to 2 mm in diameter, covering only the Achilles tendon without including adjacent soft tissues. The mean stiffness of the tendon is measured for each Q-box.

    Measured: 6 weeks and 3, 6, 12 months

  6. Achilles tendon resting angle

    Achilles tendon resting angle will be measured in flexed positions . The participant will be positioned prone with the knee passively flexed to 90 degrees on visual inspection. A goniometer will be placed on the lateral, plantar aspect of the foot is used to measure the foot angle. The stationary arm of the goniometer is aligned with the lateral midline of the lower leg, extending towards the knee, while the movable arm is aligned with the calcaneal tuberosity, parallel to the long axis of the foot. To ensure accuracy, the measurement is repeated two to three times, and the average resting angle is calculated.

    Measured: 6 weeks and 3, 6, 12 months

  7. Calf muscle strength

    Two tests will measure calf muscle strength. At weeks 6 and 3, and 6 months and 1 year, a handheld dynamometer will measure strength while lying down. At 6- and 12-month follow-up, a heel raise test will measure strength. Participants will raise their heels until they tire, with two fingertips per hand on a wall for balance. The heel raise will be done at a rate of 30 per minute, 2 seconds each, and following a metronome

    Measured: 6 weeks and 3, 6, 12 months

  8. Ankle range of motion

    The weight-bearing lunge test measures ankle dorsiflexion ROM and gauges the flexibility of the gastrocnemius and soleus muscle complex. It is a standardised test that involves standing with heels on the ground and knees aligned with the second and great toe. Participants lunge forward until their knee makes contact with the wall without lifting their heel. The distance between the big toe and the wall is then measured using a ruler

    Measured: 6 weeks; 3, 6, 12 months

  9. Jump test

    Participants will perform three one-legged counter-movement jumps on a pressure mat (Tekscan, USA) with jump height (cm) calculated from flight time. After demonstration and submaximal practice jumps, the patient executed maximal jumps from a standing position by rapidly squatting (flexing knee/hip/ankle) before exploding upward. The highest jump was recorded, with NPRS-reported Achilles tendon pain immediately post-test.

    Measured: 6 weeks; 3, 6, 12 months

  10. Tendon oxygenation and vascularity

    The pathological tendon's oxygenation and vascularity were quantified using a multiwavelength photoacoustic ultrasound (PAUS) system equipped with a 7Hz probe and dual-wavelength LED sources (850nm/750nm). The participant assumes a prone position with heels extended beyond the examination table. The probe is positioned on the target tendon, with mode-specific presets selected ("Deep PA" for vascularity at 850nm; "Deep Oxy" for oxygenation at 750nm). Each 20-second acquisition captures 200 frames, with two repeated scans per mode to ensure data reliability.

    Measured: 6 weeks; 3, 6, 12 months

  11. Thermographic tendon temperature

    Participants will be advised to avoid physical exercise and hot baths before the procedure to ensure data reliability. Each participant will rest in a seated position for 10 minutes followed by 2 minutes without socks. The room will be maintained at 20-24°C. The infrared camera will be positioned one meter from the participant, using a ThermaCam FLIR-T8210. Images will be analyzed with ThermaCAM Researcher Pro 2.8 SR-1 software, and a rectangular area covering the Achilles tendon will be used for temperature assessment.

    Measured: 6 weeks; 3, 6, 12 months

  12. Achilles Tendon Total Rupture Score

    The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure specifically designed to assess functional recovery in patients with complete Achilles tendon ruptures. This 10-item questionnaire evaluates symptoms and physical activity limitations, with each item scored on a 0-10 Likert scale (0 = severe disability/unable to perform, 10 = no disability/full function), yielding a total score ranging from 0 (worst) to 100 (best). The ATRS covers three key domains: pain (during rest and activity), functional impairment (walking, stair climbing, running, jumping), and patient confidence in the affected limb.

    Measured: 6 weeks; 3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start25 Dec 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130357
Sponsor's protocol ID
2025.416
Status last verified
Mar 2026
First submitted
12 Aug 2025
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Collagen Scaffold and Achilles tendon repair in people with Achilles Tendon Rupture, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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 Samuel K Ling, MBChB (CUHK), ChM (Edin), MRCS (+852 3505-2010, samuel.ling@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Victorian Institute of Sports Assessment (VISA-A) (time frame: 6 weeks and 3, 6, 12 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Mar 2026.

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