Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction (1vs2ham)

Rafał Kamiński

Status: Unknown

Conditions: Anterior Cruciate Ligament Injury

Treatments: Procedure: single-bundle, single-hamstring ACL reconstruction; Procedure: single-bundle, double-hamstring ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03626883

1vs2 ham

Details and patient eligibility

About

The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.

Full description

The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.

The study will recruit 60 patients per each of two arms.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear

Exclusion criteria

• revision anterior cruciate ligament surgery
• other lower limb injuries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

1 hamstring

Experimental group

Description:

Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.

Treatment:

Procedure: single-bundle, single-hamstring ACL reconstruction

2 hamstrings

Active Comparator group

Description:

Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.

Treatment:

Procedure: single-bundle, double-hamstring ACL reconstruction