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The Safety and Effectiveness of Zinc Alloy Interference Screws and Zinc-Tight Rope in Anterior Cruciate Ligament Reconstruction

The Safety and Effectiveness of Zinc Alloy Interference Screws and Zinc-Tight Rope in Anterior Cruciate Ligament Reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072163
Enrollment
Unknown
Registered
2023-06-05
Start date
2023-06-05
Completion date
Unknown
Last updated
2023-06-12

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: Zinc Alloy Interference Screws+Zinc-Tight Rope
Control group:PEEK Screws+Dynamic-Tight Rope

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged from 18 to 65 years (including 18 and 65 years), regardless of gender; 2.Voluntary informed consent; 3.Patients with clinically diagnosed ACL rupture or tear of the knee joint are clearly suitable for ACL reconstruction; 4.Contralateral knee joint function was normal; 5.The patient's skeleton is mature; 6.Good compliance, willing and able to conduct follow-up observation as required.

Exclusion criteria

Exclusion criteria: 1.Patients of childbearing age who are pregnant, breastfeeding or planning to become pregnant; 2.Patients who did not meet the diagnostic criteria for cruciate ligament rupture or tear; 3.X-ray showed patients with unclosed epiphyseal plates; 4.After internal fixation or reconstruction of knee fracture; 5.X-ray showed obvious degeneration of knee joint; 6.Patients with legs surgical in the past year; 7.Participated in any other clinical trials within the past three months; 8.Patients are known to have a history of allergy to one or more implant materials; 9.Bone severe osteoporosis affect screws implant; 10.Combined with medial and lateral collateral ligament injury (except surgical intervention); 11.Active infection of knee joint or other parts of the body; 12.Those who are physically weak or unable to tolerate surgery due to other diseases; 13.Obesity BMI>35; 14.Unable to comply with the requirements of the research program; 15.Patients considered unsuitable for inclusion in this clinical study by investigators.

Design outcomes

Primary

MeasureTime frame
Lysholm score;Fixed efficiency;

Secondary

MeasureTime frame
IKDC score;Lachman;Pivot Shift test;knee range of motion;Relative tibial anterior displacement;The upper, middle and lower diameters of the tibial bone tunnel;Fixed efficiency of Zinc Alloy Interference Screws and Zinc-Tight Rope;

Countries

China

Contacts

Public ContactJianquan Wang

Peking University Third Hospital

kenyl4172@vip.sina.com+86 10 8226 4502

Outcome results

None listed

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