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Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01025895
Enrollment
60
Registered
2009-12-04
Start date
2010-01-31
Completion date
2013-01-31
Last updated
2009-12-04

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

Conditions

Anterior Cruciate Ligament Tear

Keywords

arthroscopic surgical procedure

Brief summary

ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.

Interventions

PROCEDUREacl reconstruction - double bundle technique
PROCEDUREacle reconstruction - single bundle technique

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* knee instability with a history of ACL tear * diagnosed ACL tear according to MRI * age range 16-40.

Exclusion criteria

* previous surgery in the knees * multiple ligament raptures * partial ACL tear * severe cartilage degeneration * genovaruse/genovalgus * thin hamstrings tendons * oper epiphysis in the knee joint * patient with muscle/neurological problem that increases the tendency to fall

Design outcomes

Primary

MeasureTime frame
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Testpre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026