Knee InjuriesNCT02540811
Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
A study testing dCELL® ACL Scaffold in people with Knee Injuries, run by Tissue Regenix Ltd at 8 sites in 3 countries.
Trial summary
The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- dCELL® ACL Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Sep 2015to 11 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with partial or complete tear of the ACL and require reconstruction of the ACL.
- Medial Collateral Ligament (MCL) injury grade 2 or less.
- Osteoarthritis grade 2 or less on the Kellgren Lawrence scale.
- Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol.
Who cannot join
- Body Mass Index (BMI) greater than 35 kg/m2.
- Treatment with any investigational drug or device within two months prior to screening.
- Patients presenting with abnormal degenerative osteoarthritis of the joint.
- Previous ACL reconstruction on the target knee.
- Current ACL injury on contralateral knee.
- Patients using anticoagulants within 2 weeks prior to surgery.
Show all 9Show fewer
- Patients on current immuno-suppressive or radiation therapy within six months of screening.
- Patients with diabetes or cardiovascular disease which precludes elective surgery.
- Patients with documented renal disease or metabolic bone disease.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Spain4 sites
Hospital Universitari de Bellvitage
Barcelona, L'Hospilatet de Llobregat, 08907
Hospital Infanta Elena de Madrid-Valdemoro
Madrid, Avd. Reyes Catolicos, 21, 28342
Hospital Clinico San Carlos
Madrid, Calle Profesor Martin Lagos, 28001
Hospital Universitario La Ribera de Alzira
Valencia, Carretera Corbera, Km1, 46600
Poland2 sites
Med-Polonia Sp. z o.o.
Poznan, Ul. Obornicka 262, 60-406
Klinika Chirurgii Endoskopowej Sp. z o.o.
Żory, Ul. Bankowa 2, 44-240
United Kingdom2 sites
Robert Jones and Agnes Hunt Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
Clifton Park Hospital
York, North Yorkshire, YO30 5RA
About this study
Official title: A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.
Read the detailed description
The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties.
The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.
- Conditions
- Knee Injuries
- Being tested
- dCELL® ACL Scaffold
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCELL® ACL ScaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| dCELL® ACL Scaffold | Experimental | Not described Receives: Device: dCELL® ACL Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthrometric measurement of knee joint laxity
Comparison of the magnitude of side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device
Measured: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Lachman Test
Clinical assessment of knee stability
Measured: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Pivot Shift Test
Clinical assessment of knee stability
Measured: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Number of Participants With Treatment-Related Adverse Events
The frequency and seriousness of any adverse events or adverse device effects will be assessed
Measured: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary outcomes (2)
Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function
Patient's subjective score of 1 to 100 points, with 100 implying the best results and 1 the worst results
Measured: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Evidence of integration of the investigational product by MRI
Changes to the articular cartilage or joint space at follow up time points compared to pre-surgery
Measured: Baseline, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion11 Aug 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tissue Regenix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Roberts, Principal investigator, The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540811
- Sponsor's protocol ID
- TRG-A01-01
- Status last verified
- Nov 2022
- First submitted
- 26 Aug 2015
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT02540811
- Acronym / sponsor ID
- TRG-A01-01
- Conditions
- Knee Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tissue Regenix LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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 safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.
Detailed description
The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties.
The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dCELL® ACL Scaffold | Experimental | Device: dCELL® ACL Scaffold |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with partial or complete tear of the ACL and require reconstruction of the ACL.
- Medial Collateral Ligament (MCL) injury grade 2 or less.
- Osteoarthritis grade 2 or less on the Kellgren Lawrence scale.
- Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol.
Key exclusion criteria (9 listed)
- Body Mass Index (BMI) greater than 35 kg/m2.
- Treatment with any investigational drug or device within two months prior to screening.
- Patients presenting with abnormal degenerative osteoarthritis of the joint.
- Previous ACL reconstruction on the target knee.
- Current ACL injury on contralateral knee.
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 |
|---|---|---|
| dCELL® ACL Scaffold | Device | dCELL® ACL Scaffold |
Primary outcome
Arthrometric measurement of knee joint laxity
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Comparison of the magnitude of side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device
Lachman Test
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Pivot Shift Test
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Number of Participants With Treatment-Related Adverse Events
Time frame: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
The frequency and seriousness of any adverse events or adverse device effects will be assessed
2 secondary outcomes
Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Evidence of integration of the investigational product by MRI
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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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.
Simon Roberts principal investigator
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCELL® ACL Scaffold in people with Knee Injuries, run by Tissue Regenix Ltd at 8 sites in 3 countries.
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 4 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Poland, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Arthrometric measurement of knee joint laxity (time frame: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months). The study lists 4 primary outcomes in all. 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 30 Nov 2022.