All-inside versus complete tibial tunnel ACL reconstruction using hamstring grafts
Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
This trial will test whether the all-inside or the complete tibial tunnel surgical technique leads to better recovery in adults (18–65) having ACL reconstruction with hamstring grafts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Indonesia University Academic / other |
| Locations | 2 sites (Depok and 1 other locations) |
| Trial ID | NCT07023653 on ClinicalTrials.gov |
What this trial studies
This is a double-blind randomized controlled trial comparing functional outcomes after ACL reconstruction using hamstring grafts performed with either an all-inside technique or a complete tibial tunnel technique. Adult patients aged 18–65 with ACL rupture will be randomized to one of the two surgical approaches. Outcomes including tibial translation, pain severity, IKDC score, and Tegner activity score will be measured by anamnesis and physical examination at 3, 6, 9, and 12 months postoperatively. The trial is conducted at Indonesian University Hospital in Depok and Cipto Mangunkusumo Hospital in Jakarta.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 years old with an isolated anterior cruciate ligament rupture who are eligible for hamstring autograft reconstruction and can attend scheduled follow-up visits.
Not a fit: Patients with multiple ligament knee injuries, severe osteochondral defects (ICRS 4), active knee joint inflammation, or who are pregnant are unlikely to receive benefit from this trial.
Why it matters
Potential benefit: If successful, the preferred technique could reduce postoperative pain and improve knee stability and overall function after ACL reconstruction.
How similar studies have performed: Previous randomized and observational studies comparing all-inside and full-tunnel techniques have reported mixed but generally promising results for the all-inside approach in lowering donor-site morbidity and early postoperative pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with anterior cruciate ligament rupture * Patients within the age range of 18 to 65 years Exclusion Criteria: * Patients with Multiple Ligament Injuries in the Knee Joint * Patients with a pregnancy condition * Patients with Severe Osteochondral Defect (ICRS 4) * Patients with signs of inflamation in knee joint
Where this trial is running
Depok and 1 other locations
- Indonesian University Hospital — Depok, Indonesia (Recruiting)
- Cipto Mangunkusumo Hospital — Jakarta Pusat, Indonesia (Recruiting)
Study contacts
- Principal investigator: Prof. Dr. dr. Andri M.T. Lubis SpOT (K) — Indonesia University
- Study coordinator: Prof. Dr. dr. Andri M.T. Lubis SpOT (K)
- Email: andri_lubis@yahoo.com
- Phone: +628161177078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.