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NCT Number: NCT04012567

Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese

The objective of this study is to compare the safety and effectiveness of Biosure Regenesorb Interference Screw versus BIOSURE HA Interference Screw (control device) in patients requiring reconstruction of cruciate ligaments of the knee. The trial results will be used for registration of Biosure Regenesorb Interference Screw in China.

The primary efficacy endpoint of this study is Lysholm score at 12 months after operation. The non-inferiority testing is performed for efficiency of primary efficacy endpoint, and the test hypothesis is as follows:

Invalid hypothesis: H0: μ1-μ2 ≤-δ Alternative hypothesis: H1: μ1-μ2 > -δ, where, μ1 and μ2 are the Lysholm scores in the investigational group and control group, respectively. δ is a non-inferiority critical value.

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Key information

Conditions

Cruciate Ligament Reconstruction Knee

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong, China

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About this study

The clinical trial is designed to be a prospective, multi-center, randomized, evaluator-blinded, parallel-controlled, non-inferiority trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must meet all of the inclusion criteria:
  • Signing the Informed Consent Form (ICF) voluntarily;
  • Patients aged 18-75 years;
  • Patients clinically diagnosed with knee cruciate ligaments rupture or tear and suitable for cruciate ligaments reconstruction definitely;
  • Normal contralateral knee joint.

Exclusion criteria

  • Subjects with any of the following characteristics must be excluded from participation in the study:
  • Patients not complying with the diagnosis criteria for cruciate ligaments rupture or tear;
  • Patients with an unclosed epiphyseal plate shown on the X-ray film;
  • Patients having underwent internal fixation or reconstruction due to a knee joint fracture;
  • Patients with obvious knee joint degeneration shown on the X-ray film;
  • Patients who cannot make a knee flexion of not less than 90° during operation;
  • Patients undergoing autologous chondrocyte implantation;
  • Patients with medial meniscus or lateral meniscus completely resected;
  • Patients with significant anatomical abnormalities;
  • Pregnant or breast-feeding females or those at a child-bearing age planning to become pregnant;
  • Patients with serious osteoporosis that affects screw implantation;
  • Patients with a malignant tumor that causes failure to effectively fix the implant;
  • Known hypersensitivity to the implant materials;
  • Patients not suitable for operation due to obvious local or systemic infection;
  • Patients who cannot tolerate an operation due to severe malnutrition;
  • Patients with severe coagulation disorder (judged by the investigator), e.g. the hemophiliac;
  • Patients with immunodeficiency, including those who must receive immunosuppressant for a long time;
  • Patients with extensive skin diseases;
  • Obese patients having a Body Mass Index (BMI) > 35;
  • Patients who cannot cooperate in postoperative rehabilitation due to a severe mental disease or those who cannot tolerate the operation due to a cardiopulmonary disease;
  • Patients who received operation on the injured lower limb within the past 1 year;
  • Patients who participated in any other clinical trial within the past three months;
  • Patients who cannot follow the requirements described in the study protocol; and
  • Other patients who are considered by the investigator not suitable for this clinical study.

Treatment and study plan

Investigational device: Biosure Regenesorb Interference Screw

Device

The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material made of PLGA, β-TCP and calcium sulfate, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Its open structural design enables rapid bone ingrowth to make the screw integrated with bone tissues so as to promote healing.

Control device: BIOSURE HA Interference Screw

Device

BIOSURE HA Interference Screws and Drivers are designed for durability and reduced screw breakage. Both the screws and driver have been enhanced to allow screws to fully seat on the driver all the way to the tip of the screw, helping stress distribution and force transfer. The screw design also incorporates a consistent wall thickness throughout the length of the screw for added durability and features a tapered body for ideal ease of insertion.

Primary outcomes

  1. Lysholm Knee Scoring Scale 12 Months After Operation

    Time frame: 12 months

    Lysholm Knee Scoring Scale evaluates functions of participants based on 8 items: limp, support, interlocking, pain, instability, swelling, stair climbing and squatting. The total Lysholm score is 0-100. Pain and instability account for a higher proportion in this score. The knee functions of patients are considered excellent when the score is 95-100, good when 84-94, fair when 65-83 and poor when less than 65 (i.e., 100 is best outcome and 0 is the worst outcome).

Secondary outcomes

  1. Lysholm Knee Scoring Scale Pre-Operation and 6 Months & 24 Months After Operation

    Time frame: Pre-Operation, Post-Operation 6 months, 24 months

    Lysholm Knee Scoring Scale evaluates functions of participants based on 8 items: limp, support, interlocking, pain, instability, swelling, stair climbing and squatting. The total Lysholm score is 0-100. Pain and instability account for a higher proportion in this score. The knee functions of patients are considered excellent when the score is 95-100, good when 84-94, fair when 65-83 and poor when less than 65 (i.e., 100 is best outcome and 0 is the worst outcome).

  2. International Knee Documentation Committee (IKDC) Score

    Time frame: Pre-Operation, Post-Operation 6 months, 12 months, 24 months

    The International Knee Documentation Committee (IKDC) score is composed of a knee evaluation form (10 items) and a knee ligament examination form (8 items), involving joint pain, sport level and ability of daily activities. The total score is transformed to a scale ranging from 0 to 100, where 0 represents the lowest level of knee function and highest level of symptoms (i.e., worst outcome), and 100 represents the highest level of knee function and lowest level of symptoms (i.e., best outcome).

  3. Drawer Test: Anterior

    Time frame: Post-Operation 6 months, 12 months, 24 months

    The Anterior Drawer Test is used for anterior cruciate ligament (ACL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees and the foot stabilized flat on the table. The examiner then grasped the tibia and applied an anterior force to assess displacement. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated forward straight instability, defined as the tibia being displaced forward by 5 millimeters (mm) or more compared to the uninjured side.

  4. Drawer Test: Posterior

    Time frame: Post-Operation 6 months, 12 months, 24 months

    The Posterior Drawer Test is used for posterior cruciate ligament (PCL) examination with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed at 90 degrees. The examiner placed both hands on the proximal lower leg (just below the knee joint) with thumbs on the tibial tuberosity then attempted to translate the lower leg posteriorly. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated a lack of end feel or excessive posterior translation.

  5. Lachman Test

    Time frame: Post-Operation 6 months, 12 months, 24 months

    The Lachman Test assessed integrity of the anterior cruciate ligament (ACL) with an outcome of either negative or positive. The test was performed with the participant lying supine with the knee flexed to 20-30 degrees and the injured limb slightly rotated outward. The examiner immobilized the lower end of the femur with one hand and pressed the posterior side of the upper end of the tibia forward or backward. The test outcome was measured by the number of participants with a negative or positive result. A positive test indicated excessive anterior translation of the tibia greater than the uninjured side along with a soft end feel.

  6. Imaging Evaluation: X-ray

    Time frame: Post-Operation 6 months, 12 months, 24 months

    Radiographic assessment taken from x-ray images to evaluate the general view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.

  7. Imaging Evaluation: Computed Tomography (CT)

    Time frame: Post-Operation 6 months, 12 months, 24 months

    Radiographic assessment taken from Computed Tomography (CT) images to evaluate specific view of bone. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.

  8. Imaging Evaluation: Magnetic Resonance Imaging (MRI)

    Time frame: Post-Operation 6 months, 12 months, 24 months

    Radiographic assessment taken from Magnetic Resonance Imaging (MRI) to evaluate ligament. The assessment measured the number of participants categorized with either a normal or abnormal imaging evaluation.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-center, Randomized Clinical Study to Evaluate the Safety and Effectiveness of Biosure Regenesorb Interference Screw in Arthroscopic Reconstruction of Cruciate Ligaments in Chinese Patients

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 9, 2019
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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