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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Injury
• Intervention / Treatment: Procedure: single-bundle, single-hamstring ACL reconstruction; Procedure: single-bundle, double-hamstring ACL 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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Woj. Mazowieckie
    • Otwock, Woj. Mazowieckie, Poland, 05-400
      • Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• revision anterior cruciate ligament surgery
• other lower limb injuries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 hamstring; Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.	Procedure: single-bundle, single-hamstring ACL reconstruction; anterior cruciate ligament reconstruction with single hamstring tendon
Active Comparator: 2 hamstrings; Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.	Procedure: single-bundle, double-hamstring ACL reconstruction; anterior cruciate ligament reconstruction with 2 hamstring tendons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points	up to 5yrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks	Anderson, AF. Rating scales. In: Fu, FH.; Harner, CD.; Vince, KL., editors. Knee surgery. Baltimore: Williams & Wilkins; 1994. p. 275-96.	up to 5yrs
Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs	Knee injury and Osteoarthritis Outcome Score minimum score:0, maximum score:100 Baltimore: Williams & Wilkins; 1994. p. 275-96.	up to 5yrs
Change from baseline Lysholm Knee Questionnaire at 104 weeks	Knee function questionnaire (patient-administered), minimum score: 0, maximum score: 100. Full description in: Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982; 10:150-4. [PubMed: 6896798]	up to 5yrs
Change from baseline Visual Analog Scale for Pain at 104 weeks	Separate Outcome Measure, with minimum 0 and maximum of 10. Full description in: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi:10.1002/acr.20543.	up to 5yrs
Change from baseline tunnel volume at 104 weeks	Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively	104-weeks postop
Change from baseline tunnel diameter at 104 weeks	Change from baseline tunnel diameter will be calculated on standing knee x-rays at 104 weeks postoperatively	104-weeks postop
Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks	The medical records will be prospectively abstracted and analyzed for any arthrocentesis, revision surgery or additional procedures performed in the study group up top 104 weeks after index surgery.	up to 5yrs

Collaborators and Investigators

• Sponsor: Rafał Kamiński
• Investigators: Principal Investigator: Marcin K Wasko, M.D., Ph.D., Centre for Postgraduate Medical Education in Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): January 30, 2020
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: arthroscopy
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 1vs2 ham

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No