Multiligament Knee InjuriesNCT05655156
OrthoPureXT Multiligament PMCF Study
A study testing OrthoPure XT in people with Multiligament Knee Injuries, run by Tissue Regenix Ltd at 1 site in United Kingdom.
Trial summary
To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiligament Knee Injuries
- What is being tested?
- OrthoPure XT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2025to Dec 2026
- 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
- Male and female patients aged 18 years old or above.
- Adults suffering with multiple knee ligament injuries.
- Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol.
Who cannot join
- Those unable to give consent.
- Those considered as conflicting variables by the investigator. This may include, but is not limited to:
- Open trauma
- Neurovascular emergencies
- Compartment syndrome
- Life threatening injury
Show all 17Show fewer
- Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:
- Associated fractures that require external fixators
- Local severe concomitant injuries
- Injuries to other parts of the body associated with a high level of daily activity/intervention for the patient
- Those considered as a poor candidate for surgery by the investigator.
- If female and of child-bearing potential must not have a positive pregnancy test at Visit
- 1 nor have a stated intention to become pregnant in the next 12 months.
- Those patients contraindicated for in the IFU, i.e.:
- Showing signs of infection within 24 hours prior to surgery
- Patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material
- Patients unable or unwilling to follow the post-operative care and rehabilitation programme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
About this study
Official title: Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.
Read the detailed description
OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.
28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.
Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:
- Posterior cruciate ligament (PCL)
- Anterior cruciate ligament (ACL)
- Posteromedial corner including the medial collateral ligament (MCL)
- Posterolateral corner including the lateral collateral ligament (LCL)
- Conditions
- Multiligament Knee Injuries
- Being tested
- OrthoPure XT
- Keywords
- MLKI, PMCF, ACL PCL MCL LCL, IKDC, KOOS, Lysholm, Xenograft, MLKIs, Knee reconstruction, Knee injuries
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoPure XTDevice
Indication: reconstruction of knee ligaments to restore knee function and stability
The following device sizes are available for use in this indication:
- Size 5
- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction)
- Size 6
- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction)
- Size 8
- Primary ACL reconstruction where autograft tissue is not suitable
- Revision ACL reconstruction
- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction)
- Size 10
- Multi-ligament reconstruction (recommended for posterior cruciate ligament (PCL) reconstruction)
| Study group | Role | What they receive |
|---|---|---|
| Multiple Knee Ligament Injuries | Experimental | Sub-groups of n=7 incurring ligament reconstruction using OrthoPureXT in the following anatomical locations:
* Posterior cruciate ligament (PCL)
* Anterior cruciate ligament (ACL)
* Posteromedial corner including the medial collateral ligament (MCL)
* Posterolateral corner including the lateral collateral ligament (LCL) Receives: Device: OrthoPure XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change from Baseline in IKDC
Assessment of knee stability via evaluation of IKDC score.
Measured: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
Secondary outcomes (3)
A change from Baseline in Lysholm
Assessment of knee stability via evaluation of Lysholm score.
Measured: Baseline (30 days prior to surgery); 1, 3 ,6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
A change from Baseline in KOOS
Assessment of knee stability via evaluation of KOOS.
Measured: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
A change from Baseline in Assessment of Laxity via Physical Examination
Physical assessment of passive movement focusing on the reconstructed ligament.
Measured: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study startApr 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiligament 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
- Model description
- Subjects with multiligament knee injuries will be evenly distributed across potential ligament reconstruction treatment options: PCL, ACL, MCL, LCL.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tissue Regenix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655156
- Sponsor's protocol ID
- A03/0028/P01
- Status last verified
- Jul 2024
- First submitted
- 16 Nov 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
- ClinicalTrials.gov ID
- NCT05655156
- Acronym / sponsor ID
- A03/0028/P01
- Conditions
- Multiligament Knee Injuries
- Keywords
- MLKI, PMCF, ACL PCL MCL LCL, IKDC, KOOS, Lysholm, Xenograft, MLKIs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tissue Regenix LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Dec 2022 (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.
To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.
Detailed description
OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.
28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.
Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:
- Posterior cruciate ligament (PCL)
- Anterior cruciate ligament (ACL)
- Posteromedial corner including the medial collateral ligament (MCL)
- Posterolateral corner including the lateral collateral ligament (LCL)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with multiligament knee injuries will be evenly distributed across potential ligament reconstruction treatment options: PCL, ACL, MCL, LCL.
| Arm | Type | Receives |
|---|---|---|
| Multiple Knee Ligament Injuries | Experimental | Device: OrthoPure XTSub-groups of n=7 incurring ligament reconstruction using OrthoPureXT in the following anatomical locations: * Posterior cruciate ligament (PCL) * Anterior cruciate ligament (ACL) * Posteromedial corner including the medial collateral ligament (MCL) * Posterolateral corner including the lateral collateral ligament (LCL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged 18 years old or above.
- Adults suffering with multiple knee ligament injuries.
- Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol.
Key exclusion criteria (17 listed)
- Those unable to give consent.
- Those considered as conflicting variables by the investigator. This may include, but is not limited to:
- Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:
- Those considered as a poor candidate for surgery by the investigator.
- If female and of child-bearing potential must not have a positive pregnancy test at Visit
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 |
|---|---|---|
| OrthoPure XTIndication: reconstruction of knee ligaments to restore knee function and stability The following device sizes are available for use in this indication: * Size 5 - Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 6 - Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 8 * Primary ACL reconstruction where autograft tissue is not suitable * Revision ACL reconstruction * Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 10 * Multi-ligament reconstruction (recommended for posterior cruciate ligament (PCL) reconstruction) | Device | Multiple Knee Ligament Injuries |
Primary outcome
A change from Baseline in IKDC
Time frame: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
Assessment of knee stability via evaluation of IKDC score.
3 secondary outcomes
A change from Baseline in Lysholm
Time frame: Baseline (30 days prior to surgery); 1, 3 ,6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
A change from Baseline in KOOS
Time frame: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
A change from Baseline in Assessment of Laxity via Physical Examination
Time frame: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)
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 15 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Multiligament Knee Injuries
RecruitingObservational study
Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgically Treated for Isolated "Stener-like" Lesions of the Medial Collateral Ligament (MCL) or in the Context of Multiligament Injuries and Articular Fractures
Ligament Injury, Knee Injuries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrthoPure XT in people with Multiligament Knee Injuries, run by Tissue Regenix Ltd at 1 site in United Kingdom.
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 3 inclusion and 17 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 15 Apr 2025. 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 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?
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 Anna Kaniewska (+44 (0)3304303052, a.kaniewska@tissueregenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change from Baseline in IKDC (time frame: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)). 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 15 Apr 2025.