Absorbable Interface Screw Clinical Trial

NCT05431790 | Unknown DMC

• 1 other identifier: IRB00006761-D2022055
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Validation of the safety and efficacy of absorbable interface screws for clinical use

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Anterior cruciate ligament; absorbable interface screws

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At 14 months after surgery.

Secondary Outcomes (17)

• The upper, middle and lower diameters of the tibial bone tunnel

  Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.

• Relative tibial anterior displacement

  Preoperatively, 6 months postoperatively, 9 months postoperatively, and 14 months postoperatively.

• Range of motion (ROM)

  Preoperatively.

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000.

  Asked as baseline data before surgery.

• Tegner score

  Asked as baseline data before surgery.

Study Arms (2)

Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.)

EXPERIMENTAL

Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.

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.

Device: Absorbable interface screws manufactured by INION.

Interventions

Absorbable interface screws manufactured by Natong Biotechnology DEVICE

Anterior cruciate ligament reconstruction uses absorbable interface screws manufactured by Natong Biotechnology.

Absorbable screw (Natong Biotechnology (Beijing) Co., Ltd.)

Absorbable interface screws manufactured by INION. DEVICE

Reconstruction of anterior cruciate ligament using Inion Oy absorbable interface scews from INION, Finland

Absorbable screw (Inion Oy, INION, Finland)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blind the participant (Due to the particularity of implanted devices, blindness needs to be maintained as far as possible until the subject is automatically unblinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 24, 2022
• Study Start: July 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-05