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Clinical validation plan for absorbable interface nails

Clinical validation plan for absorbable interface nails

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047838
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of the anterior cruciate ligament of the knee

Interventions

Control group:Smith & Nephew absorbable interface screw
experimental group:Changchun Sinobiom Absorbable Interface Screw

Sponsors

The Third Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Gender: male or female; 3. Those who have surgical indications and intend to undergo anterior cruciate ligament reconstruction; 4. Voluntarily sign the informed consent form, and be willing to cooperate with the physician to complete the relevant treatment, examination and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who need revision surgery; 2. Bone pathological conditions such as cystic lesions or severe osteoporosis, which may affect the accuracy of drilling or prevent the implant from being firmly fixed; 3. There are lesions in the soft tissue that needs to be fixed, and these lesions will affect the reliability of the suture; 4. The comminuted bone surface will not be able to firmly fix the implant; 5. Various conditions that lead to or may lead to insufficient implant support or obstruction of recovery, obstruction of blood supply, previous infection, etc.; 6. Various conditions that may affect the patient's physical condition or recovery cycle, such as advanced age, mental illness or alcoholism; 7. Patients with severe obesity; 8. Patients who are unwilling to restrict activities and do not comply with doctor's orders; 9. Those who have other contraindications to surgery; 10. Patients deemed inappropriate by the investigator to be included.

Design outcomes

Primary

MeasureTime frame
Success rate;Tibia anterior degree;

Secondary

MeasureTime frame
Lachman test;front drawer test;Pivot Shift test;Knee Scale (Lysholm) Score;Exercise level (Tegner) score;(IKDC2000) Subjective Evaluation Scale of Knee Joint Function;pain score;Degree of swelling;

Countries

China

Contacts

Public ContactYu Jiakuo

The Third Hospital of Peking University

yujiakuo@126.com+86 13331031448

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026