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Clinical Trials/NCT03626883
NCT03626883UnknownNot Applicable

Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes

Rafał Kamiński2 sites in 1 country120 target enrollmentStarted: December 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •revision anterior cruciate ligament surgery
  • •other lower limb injuries

Outcomes

Primary Outcomes

Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points

Time Frame: up to 5yrs

Secondary Outcomes

  • Change from baseline Lysholm Knee Questionnaire at 104 weeks(up to 5yrs)
  • Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks(up to 5yrs)
  • Change from baseline tunnel volume at 104 weeks(104-weeks postop)
  • Change from baseline tunnel diameter at 104 weeks(104-weeks postop)
  • Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks(up to 5yrs)
  • Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs(up to 5yrs)
  • Change from baseline Visual Analog Scale for Pain at 104 weeks(up to 5yrs)

Investigators

Sponsor
Rafał Kamiński
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Rafał Kamiński

MD, PhD

Centre of Postgraduate Medical Education

Study Sites (2)

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