Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injury Clinical Trial

— 1vs2ham  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03626883
• Other study ID #: 1vs2 ham
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: July 30, 2022

Study information

• Verified date: February 2022
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 30, 2022
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• revision anterior cruciate ligament surgery

• other lower limb injuries

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

Procedure:
• single-bundle, single-hamstring ACL reconstruction
anterior cruciate ligament reconstruction with single hamstring tendon
• single-bundle, double-hamstring ACL reconstruction
anterior cruciate ligament reconstruction with 2 hamstring tendons

Locations

Country	Name	City	State
Poland	Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education	Otwock	Woj. Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Rafal Kaminski

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points		up to 5yrs
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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