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To evaluate the safety and efficacy of tendon allograft in the repair and reconstruction of tendon or ligament defects

To evaluate the safety and efficacy of tendon allograft in the repair and reconstruction of tendon or ligament defects——Prospective, multicenter, randomized, parallel-controlled, noninferiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065548
Enrollment
Unknown
Registered
2022-11-08
Start date
2022-12-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Tendon and ligament injuries

Interventions

Experimental group:Allogeneic tendon
control group:Autogenous tendon

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects should be aged between 18 and 65 (including 18 and 65) and of both genders; 2. Patients with clinically diagnosed anterior cruciate ligament injury requiring surgery; 3. have not participated in other clinical trials within 3 months; 4. Subjects are fully aware of the benefits and risks of this trial, are still willing to participate and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Previous history of knee surgery; 2. Patients with severe osteoarthritis (Kellgren-Lawrence grade >= III) and two or more ligament injuries requiring reconstruction and repair; 3. Absence of ipsilateral limb donor ligament; 4. pathological obesity (body mass index [BMI] >= 40); 5. Allergies, such as past medical or family history of autoimmune diseases; 6. Knee tumors, rheumatoid disease, tuberculosis, suppurative disease and complications affecting the joint structure; 7. Secondary knee arthritis accompanied by psoriasis, syphilitic neuropathy brown yellow disease, metabolic bone disease; 8. Frequent users of sedatives, sleeping pills, tranquilizers or other addictive drugs; 9. Patients with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems or mental disorders; 10. Those who cannot accept long-term and complicated rehabilitation training after operation; 11. women during family planning, lactation and pregnancy within 12 months; 12. Mentally incapacitated or unable to understand the requirements of participating in the study, e.g. unable to express, read, and understand the questions in the subject subjective questionnaire specified in the study protocol, and unable to provide feedback in appropriate language 13. Other researchers considered the candidates inappropriate for inclusion, such as failing to evaluate the efficacy.

Design outcomes

Primary

MeasureTime frame
IKDC grading score;

Secondary

MeasureTime frame
Subjective IKDC Knee score;Lysholm scale;Lachman test;Axial shift test;ADT test;

Countries

China

Contacts

Public ContactZhao Jinzhong

Shanghai Sixth People's Hospital

zhaojinzhong@vip.163.com+86 13917396491

Outcome results

None listed

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