Ligament InjuryNCT04310956
A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
A study testing Y-Knot all-suture anchor and Biocomposite suture anchor in people with Ligament Injury, run by ConMed Linvatec Beijing at 4 sites in China.
Trial summary
Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ligament Injury
- What is being tested?
- Y-Knot all-suture anchor and Biocomposite suture anchor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 4 sitesChina
- Study dates
- 23 Dec 2019to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, no less than 18 years old;
- Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot\&ankle repair surgery by investigator;
- Patient willing to sign a written consent form participating in this study；
- Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；
- Life expectancy is more than 2 years post-operationally;
Who cannot join
- Conducted surgery at index ankle and possibly influence the outcome evaluation;
- Bilateral ankle surgery;
- Suffering concurrent ankle disease that may leads to a surgery during the study phase;
- known or suspected allergies to implant and/or instrument materials;
- pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;
- With concurrent disease that may influence the index ankle function;
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- Patients with active sepsis or infection;
- With concurrent disease that may influence the stability of device and rehabilitation;
- Immune suppression, impairment of immune function, or autoimmune disease;
- Pregnant or lactating women;
- Known noncompliance or lost follow-up risk;
- Participated other drug, biologic, or device clinical trial 12 months before enrollment;
- Alcohol or drug abuser;
- Other inappropriate condition based on investigator determination;
Trial locations and contacts
4 sites in 1 country.
China4 sites
Sichuan Orthopedics Hospital
Chengdu
Qilu Hospital of Shandong University
Jinan
Huashan Hosptial
Shanghai, Shanghai Municipality, 200000
Shenzhen Second People's Hospital
Shenzhen
About this study
Official title: A Multi-center, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.
- Conditions
- Ligament Injury
- Being tested
- Y-Knot all-suture anchor, Biocomposite suture anchor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-Knot all-suture anchorDevice
Y-knot all-suture anchor will be implanted to participants
Biocomposite suture anchorDevice
Biocomposite suture anchor will be implanted to participants
| Study group | Role | What they receive |
|---|---|---|
| Y-Knot group | Experimental | Patients use Y-Knot all-suture anchor Receives: Device: Y-Knot all-suture anchor |
| Biocomposite suture anchor | Active comparator | Patients use Biocomposite suture anchor Receives: Device: Biocomposite suture anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of AOFAS score
Measured: From pre-operation to 6 months postoperative
Secondary outcomes (4)
improvement of AOFAS score
Measured: From pre-operation to 3 months postoperative
Improvement of VAS score
Measured: From pre-operation to 3 and 6 months postoperative
ligament injury recurrences
Measured: up to 6 months postoperative
secondary surgery
Measured: up to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start23 Dec 2019
- Primary completion5 May 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament InjuryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConMed Linvatec Beijing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310956
- Sponsor's protocol ID
- P18101
- Status last verified
- Aug 2021
- First submitted
- 13 Mar 2020
- Last updated
- 9 Mar 2022
- Results posted
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
- ClinicalTrials.gov ID
- NCT04310956
- Acronym / sponsor ID
- P18101
- Conditions
- Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- ConMed Linvatec BeijingIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 17 Mar 2020 (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.
Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-Knot group | Experimental | Device: Y-Knot all-suture anchorPatients use Y-Knot all-suture anchor |
| Biocomposite suture anchor | Active comparator | Device: Biocomposite suture anchorPatients use Biocomposite suture anchor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female, no less than 18 years old;
- Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot\&ankle repair surgery by investigator;
- Patient willing to sign a written consent form participating in this study；
- Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；
- Life expectancy is more than 2 years post-operationally;
Key exclusion criteria (14 listed)
- Conducted surgery at index ankle and possibly influence the outcome evaluation;
- Bilateral ankle surgery;
- Suffering concurrent ankle disease that may leads to a surgery during the study phase;
- known or suspected allergies to implant and/or instrument materials;
- pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;
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 |
|---|---|---|
| Y-Knot all-suture anchorY-knot all-suture anchor will be implanted to participants | Device | Y-Knot group |
| Biocomposite suture anchorBiocomposite suture anchor will be implanted to participants | Device | Biocomposite suture anchor |
Primary outcome
improvement of AOFAS score
Time frame: From pre-operation to 6 months postoperative
4 secondary outcomes
improvement of AOFAS score
Time frame: From pre-operation to 3 months postoperative
Improvement of VAS score
Time frame: From pre-operation to 3 and 6 months postoperative
ligament injury recurrences
Time frame: up to 6 months postoperative
secondary surgery
Time frame: up to 6 months postoperative
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 9 Mar 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y-Knot all-suture anchor and Biocomposite suture anchor in people with Ligament Injury, run by ConMed Linvatec Beijing at 4 sites in China.
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 5 inclusion and 14 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
improvement of AOFAS score (time frame: From pre-operation to 6 months postoperative). 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 9 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.