Anterior Cruciate Ligament RuptureNCT05431790
Absorbable Interface Screw Clinical Trial
A study testing Absorbable interface screws manufactured by Natong Biotechnology and Absorbable interface screws manufactured by INION. in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital.
Trial summary
Validation of the safety and efficacy of absorbable interface screws for clinical use Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Absorbable interface screws manufactured by Natong Biotechnology and Absorbable interface screws manufactured by INION.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2022to 30 Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Before surgery, subjects or guardians are willing and able to sign the informed consent;
- Patients aged 18 to 80 (including 18 and 80 years old), regardless of gender;
- Patients who meet the diagnostic criteria for anterior cruciate ligament rupture of the knee joint and have no contraindications to implantation;
- The patient's bones are mature;
- Good compliance, willing and able to conduct follow-up observation as required.
Who cannot join
- ① Subjects who have participated in other clinical studies of drugs, biological agents or medical devices before being selected and did not reach the primary study endpoint;
- The patient is known to have a history of allergy to one or more implanted materials;
- Those who are physically weak or cannot tolerate surgery due to other diseases of the body;
- Active infection in the knee joint or other parts of the body; ⑤ Those with other ligament injury and/or meniscus injury in the affected knee joint; ⑥ Those who need to perform simultaneous meniscus repair and other surgeries on the ipsilateral knee joint; ⑦ Obese BMI>35;
About this study
Official title: Absorbable Interface Screw Clinical Trial - PUTH & NANTON
Validation of the safety and efficacy of absorbable interface screws for clinical use
Read the detailed description
Interface screws are divided into metal screws and absorbable screws. Since metal screws cut tendon grafts, absorbable interface screws are now mostly selected. At present, the materials of absorbable screws are mainly polylactic acid and polyglycolide. The test product is composed of two kinds of polylactic acid and bioactive glass fiber, which can reduce the adverse stimulation to the surrounding bone, promote the absorption of the screw and the bone grow into.Estimated enrollment for 4 months, follow-up for 14 months, a total of 18 months.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Absorbable interface screws manufactured by Natong Biotechnology, Absorbable interface screws manufactured by INION.
- Keywords
- Anterior cruciate ligament, absorbable interface screws
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable interface screws manufactured by Natong BiotechnologyDevice
Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.
Absorbable interface screws manufactured by INION.Device
Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland
| Study group | Role | What they receive |
|---|---|---|
| Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.) | Experimental | Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology. Receives: Device: Absorbable interface screws manufactured by Natong Biotechnology |
| Absorbable screw (Inion Oy, INION, Finland) | Active comparator | Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by INION. Receives: Device: Absorbable interface screws manufactured by INION. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Measured: Asked as baseline data before surgery.
Lysholm score
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Measured: At 6 months after surgery.
Lysholm score
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Measured: At 9 months after surgery.
Lysholm score
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Measured: At 14 months after surgery.
Secondary outcomes (17)
The upper, middle and lower diameters of the tibial bone tunnel
The tunnel widening of the experimental group was measured compared with that of the control group.
Measured: Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group can effectively limit the anterior displacement of the tibia relative to the femur.
Measured: Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Measured: Preoperatively.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000.
Currently, there are internationally recognized scales with reliability, validity and sensitivity for the assessment of anterior cruciate ligament injury and rupture. Subjective and objective symptoms of the knee joint were comprehensively assessed.
Measured: Asked as baseline data before surgery.
Tegner score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Measured: Asked as baseline data before surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Currently, there are internationally recognized scales with reliability, validity and sensitivity for the assessment of anterior cruciate ligament injury and rupture. Subjective and objective symptoms of the knee joint were comprehensively assessed.
Measured: At 6 months after surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Currently, there are internationally recognized scales with reliability, validity and sensitivity for the assessment of anterior cruciate ligament injury and rupture. Subjective and objective symptoms of the knee joint were comprehensively assessed.
Measured: At 9 months after surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Currently, there are internationally recognized scales with reliability, validity and sensitivity for the assessment of anterior cruciate ligament injury and rupture. Subjective and objective symptoms of the knee joint were comprehensively assessed.
Measured: At 14 months after surgery.
Tegner score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Measured: At 6 months after surgery.
Tegner score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Measured: At 9 months after surgery.
Tegner score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Measured: At 14 months after surgery.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group
Measured: At 6 months postoperatively.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group
Measured: At 9 months postoperatively.
Relative tibial anterior displacement
To compare whether the absorbable interface screws in the experimental group
Measured: At 14 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Measured: At 6 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Measured: At 9 months postoperatively.
Range of motion (ROM)
Assessing active and passive flexion-extension angles after anterior cruciate ligament surgery
Measured: At 14 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Model description
- Random assignment of patients with anterior cruciate ligament reconstruction (The test group uses the test product; the control group uses the marketed product)Blind the subjects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431790
- Sponsor's protocol ID
- IRB00006761-D2022055
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Interface Screw Clinical Trial - PUTH & NANTON
- ClinicalTrials.gov ID
- NCT05431790
- Acronym / sponsor ID
- IRB00006761-D2022055
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior cruciate ligament, absorbable interface screws
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Jun 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.
Validation of the safety and efficacy of absorbable interface screws for clinical use
Detailed description
Interface screws are divided into metal screws and absorbable screws. Since metal screws cut tendon grafts, absorbable interface screws are now mostly selected. At present, the materials of absorbable screws are mainly polylactic acid and polyglycolide. The test product is composed of two kinds of polylactic acid and bioactive glass fiber, which can reduce the adverse stimulation to the surrounding bone, promote the absorption of the screw and the bone grow into.Estimated enrollment for 4 months, follow-up for 14 months, a total of 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Random assignment of patients with anterior cruciate ligament reconstruction (The test group uses the test product; the control group uses the marketed product)Blind the subjects.
| Arm | Type | Receives |
|---|---|---|
| Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.) | Experimental | Device: Absorbable interface screws manufactured by Natong BiotechnologyAnterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology. |
| Absorbable screw (Inion Oy, INION, Finland) | Active comparator | Device: Absorbable interface screws manufactured by INION.Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by INION. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ① Before surgery, subjects or guardians are willing and able to sign the informed consent;
Key exclusion criteria (4 listed)
- ① Subjects who have participated in other clinical studies of drugs, biological agents or medical devices before being selected and did not reach the primary study endpoint;
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 |
|---|---|---|
| Absorbable interface screws manufactured by Natong BiotechnologyAnterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology. | Device | Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.) |
| Absorbable interface screws manufactured by INION.Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland | Device | Absorbable screw (Inion Oy, INION, Finland) |
Primary outcome
Lysholm score
Time frame: Asked as baseline data before surgery.
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING. Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Time frame: At 6 months after surgery.
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING. Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Time frame: At 9 months after surgery.
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING. Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Time frame: At 14 months after surgery.
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING. Year introduced: 2015 Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
17 secondary outcomes
The upper, middle and lower diameters of the tibial bone tunnel
Time frame: Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
Relative tibial anterior displacement
Time frame: Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.
Range of motion (ROM)
Time frame: Preoperatively.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000.
Time frame: Asked as baseline data before surgery.
Tegner score
Time frame: Asked as baseline data before surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Time frame: At 6 months after surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Time frame: At 9 months after surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Time frame: At 14 months after surgery.
Tegner score
Time frame: At 6 months after surgery.
Tegner score
Time frame: At 9 months after surgery.
Tegner score
Time frame: At 14 months after surgery.
Relative tibial anterior displacement
Time frame: At 6 months postoperatively.
Relative tibial anterior displacement
Time frame: At 9 months postoperatively.
Relative tibial anterior displacement
Time frame: At 14 months postoperatively.
Range of motion (ROM)
Time frame: At 6 months postoperatively.
Range of motion (ROM)
Time frame: At 9 months postoperatively.
Range of motion (ROM)
Time frame: At 14 months postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable interface screws manufactured by Natong Biotechnology and Absorbable interface screws manufactured by INION. in people with Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital.
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 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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Lysholm score (time frame: Asked as baseline data before surgery.). 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 24 Jun 2022; AzTrials last refreshed its copy on 28 Oct 2026.