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Clinical trial of new therapy for anterior cruciate ligament reconstruction with the use of autologous injured tissue

Phase 1
Conditions
Anterior cruciate ligament injury
Registration Number
JPRN-UMIN000007285
Lead Sponsor
Kobe University Graduate School of Medicine
Brief Summary

Ten patients were devided into two group. One is the tissue group, in which double bundle anterior-cruciate regament reconstruction (DB-ACLR) was performed with ruptured tissue and the other is the control group, in which DB-ACLR was performed without tissue. Clinical outcomes including Lysholm score, anteroposterior stability by KT-1000, and rotational stability by pivot shift test showed no significant differences between the two groups. However, especially at the femoral side, reduction of tunnel enlargement was significantly found in the tissue group compred with the control group.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients receiving radiation, chemotherapy, immunosuppression, or chronic steroids 2) Patients with complete neuropathy that would interfere with walking or appreciation of pain 3) 4000<WBC<10000 4) Patients with active infection systemically or at the site of knee 5) Patients joining in another clinical study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical outcom at 3, 6, and 12 months after surgery (Lysholm score)
Secondary Outcome Measures
NameTimeMethod
Computer tomography at 6 and 12 months after surgery
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