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A prospective, multicenter, randomized, parallel controlled, non inferior clinical trial to evaluate the efficacy and safety of absorbable interface screw in the reconstruction of knee cruciate ligament rupture

A prospective, multicenter, randomized, parallel controlled, non inferior clinical trial to evaluate the efficacy and safety of absorbable interface screw in the reconstruction of knee cruciate ligament rupture

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050828
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-09-09
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Anterior cruciate ligament reconstruction

Interventions

Experimental group:HercuRegen absorbable interface screws
Control group:Intervention screw

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, regardless of gender; 2. The subjects voluntarily participated in the trial, signed written informed consent, and were willing to cooperate with doctors to complete relevant treatment, examination and follow-up; 3. Those who have surgical indications and intend to perform knee cruciate ligament reconstruction.

Exclusion criteria

Exclusion criteria: 1. Patients requiring revision surgery; 2. Bone cystic lesions or severe osteoporosis affect the accuracy of surgery or make the implant unable to be fixed effectively; 3. The soft tissue that needs to be fixed has lesions, which affects the reliability of suture; 4. Comminuted bone surface; 5. Obese patients with body mass index (BMI) > 35; 6. Allergic to implant materials; 7. Those who have old age and mental diseases, resulting in inability to understand the informed consent form; 8. Pregnant or lactating; 9. Those who have participated in other clinical trials within three months; 10. The investigator believes that other reasons are not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Lysholm score;Success rate of ligament fixation;Range of motion (ROM);

Secondary

MeasureTime frame
Tegner and the international knee documentation committee knee uation form(IKDC) scores;Lachman test;Pivot Shift test;Visual analogue score of knee pain;Swelling degree;

Countries

China

Contacts

Public ContactZhao Jinzhong

Shanghai Sixth People's Hospital

zhaojinzhong@vip.163.com+86 18930177160

Outcome results

None listed

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