PEEK Interference Screw; Fixation; Anterior Cruciate Ligament ReconstructionPhase 3NCT03342222
The Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
A Phase 3 study testing Interference Screws in people with PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction, run by Central South University at 1 site in China.
Trial summary
Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Interference Screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2017to 20 Nov 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form; Between the ages of 18 and 75; Positive ADT and positive Lachman test. Unilateral anterior cruciate ligament is confirmed by MRI (without posterior cruciate ligament injury or reconstruction); Tolerated for anterior cruciate ligament reconstruction surgery; Normal contralateral knee
Who cannot join
- Do not meet the diagnostic criteria of anterior cruciate ligament injury;
- With posterior cruciate ligament fracture at the same time;
- X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury);
- Knee flexion less than 90 degree;
- Abnormal body anatomy;
- Pregnant, breast-feeding or subjects who plan to become pregnant;
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- Serious osteoporosis, malignant tumors;
- Allergic to implant materials;
- Patients with severe malnutrition who can not tolerate surgery;
- Severe coagulopathy, such as hemophilia;
- Immunodeficiency diseases, including those requiring long-term use of immunosuppressive agents;
- The injured knee has a wide range of skin diseases;
- Serious obese patients (BMI> 35);
- Patients with severe mental illness can not cooperate with postoperative rehabilitation and patients with severe cardiopulmonary disease can not tolerate surgery;
- Ipsilateral lower extremity received surgery within the past year;
- Has participated in any other clinical trial in the past three months;
- Can not comply with the requirements of the study;
- Those who the investigator thinks they are inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Lu Hongbin, M.D. & Ph.D., 86-0731-84327174, hongbinlu@hotmail.com
About this study
Official title: Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions.
120 Subjects with ACL injury were randomly assigned to two groups for ACL reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference screw (Smith \& Nephew plc). The subjects will be followed by 12 months after surgery for evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.
- Being tested
- Interference Screws
- Keywords
- PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interference ScrewsDevice
tibial fixation for ACL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| PEEK Interference Screws | Experimental | PEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd. Receives: Device: Interference Screws |
| Biosure PK interference screw | Active comparator | Biosure PK interference screw from Smith \& Nephew plc. Receives: Device: Interference Screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with Lysholm score more than 70 score
Measured: 12 month
Secondary outcomes (4)
Lysholm score
Measured: 1month; 3month; 6 month; 12 month
IKDC
Measured: 1month; 3month; 6 month; 12 month
Anterior drawer test
Measured: 1month; 3month; 6 month; 12 month
Lachman test
Measured: 1month; 3month; 6 month; 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start20 Nov 2017
- Primary completion20 Nov 2019 (estimated)
- Study completion20 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PEEK Interference Screw; Fixation; Anterior Cruciate Ligament ReconstructionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Rejoin Hangzhou Martins Medical Equipment Co., Ltd.
- Responsible party
- Principal investigator, Hongbin Lu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342222
- Sponsor's protocol ID
- JMST-01
- Status last verified
- Apr 2018
- First submitted
- 9 Nov 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Open, Parallel, Noninferiority Clinical Trial to Evaluate the Safety and Effectiveness of PEEK Interference Screws in Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03342222
- Acronym / sponsor ID
- JMST-01
- Keywords
- PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Rejoin Hangzhou Martins Medical Equipment Co., Ltd.
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Nov 2019 (estimated)
- Study completion
- 20 Nov 2019 (estimated)
- First posted
- 14 Nov 2017 (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.
Anterior cruciate ligament (ACL) rupture is one of the most common injuries in sports medicine. ACL reconstructions are usually performed to restore the stability of knee joint and prevent the secondary meniscal and chondral lesions.
120 Subjects with ACL injury were randomly assigned to two groups for ACL reconstruction.Group one: tibial fixation with PEEK Interference Screws (Rejoin Hangzhou Martins Medical Equipment Co., Ltd.);Group two: tibial fixation with Biosure PK interference screw (Smith \& Nephew plc). The subjects will be followed by 12 months after surgery for evaluations.Outcome measures included Lysholm score,IKDC, ADT,Lachman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK Interference Screws | Experimental | Device: Interference ScrewsPEEK Interference Screws provided by Ruijin Hangzhou Martins Medical Equipment Co., Ltd. |
| Biosure PK interference screw | Active comparator | Device: Interference ScrewsBiosure PK interference screw from Smith \& Nephew plc. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntarily sign the informed consent form; Between the ages of 18 and 75; Positive ADT and positive Lachman test. Unilateral anterior cruciate ligament is confirmed by MRI (without posterior cruciate ligament injury or reconstruction); Tolerated for anterior cruciate ligament reconstruction surgery; Normal contralateral knee
Key exclusion criteria (18 listed)
- Do not meet the diagnostic criteria of anterior cruciate ligament injury;
- With posterior cruciate ligament fracture at the same time;
- X-ray showed a significant degeneration of the knee (more than four degrees of cartilage injury);
- Knee flexion less than 90 degree;
- Abnormal body anatomy;
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 |
|---|---|---|
| Interference Screwstibial fixation for ACL reconstruction | Device | Biosure PK interference screw, PEEK Interference Screws |
Primary outcome
percentage of patients with Lysholm score more than 70 score
Time frame: 12 month
4 secondary outcomes
Lysholm score
Time frame: 1month; 3month; 6 month; 12 month
IKDC
Time frame: 1month; 3month; 6 month; 12 month
Anterior drawer test
Time frame: 1month; 3month; 6 month; 12 month
Lachman test
Time frame: 1month; 3month; 6 month; 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interference Screws in people with PEEK Interference Screw; Fixation; Anterior Cruciate Ligament Reconstruction, run by Central South University at 1 site 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 1 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 30 Apr 2018. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi He, MD (86-073189753059, hongbinlu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with Lysholm score more than 70 score (time frame: 12 month). 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 Apr 2018.