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ACL Reconstruction with or without Internal Brace: Postoperative Outcomes in a Randomized Control Trial

To assess the postoperative outcome of Anterior Cruciate Ligament (ACL) reconstruction with and without internal brace augmentation: A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109611
Enrollment
58
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: M238- Other internal derangements of knee

Interventions

Intervention1: ACL reconstruction with Internal Brace augmentation: ACL reconstruction using hamstring/peroneous autograft with ligament augmentation (suture fibre tape reinforcement) via suspensory f

Sponsors

Suprio Santra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients are willing to provide informed consent to participate in the study and commit to follow-up visits and assessments. Patients with isolated ACL injuries, without concurrent major ligamentous injuries (e.g., posterior cruciate ligament, collateral ligaments). Patients with no history of prior ACL reconstruction surgery on the affected knee. Patients without significant comorbidities or medical conditions that could interfere with surgery or postoperative recovery. Patients with objective signs of ACL deficiency on clinical examination (positive Lachman test, pivot-shift test, or anterior drawer test) and confirmed through imaging (MRI or arthroscopy).

Exclusion criteria

Exclusion criteria: Patients with concurrent injuries involving multiple major ligaments of the knee. Patients with a history of previous ACL reconstruction on the same knee. Patients with active systemic or local infections

Design outcomes

Primary

MeasureTime frame
Functional scores (IKDC, Lysholm, Tegner scores)Timepoint: 6 weeks, 3 months, 6 months

Secondary

MeasureTime frame
pain, knee stability, and complications.Timepoint: 6 weeks, 3 months, 6 months

Countries

India

Contacts

Public ContactSuprio Santra

Rajendra Institute of Medical Sciences

gkgupta1975@yahoo.co.in07979014287

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026