Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction (1vs2ham)
Primary Purpose
Anterior Cruciate Ligament Injury
Status
Active
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
single-bundle, single-hamstring ACL reconstruction
single-bundle, double-hamstring ACL reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring arthroscopy
Eligibility Criteria
Inclusion Criteria:
- chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
Exclusion Criteria:
- revision anterior cruciate ligament surgery
- other lower limb injuries
Sites / Locations
- Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 hamstring
2 hamstrings
Arm Description
Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.
Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.
Outcomes
Primary Outcome Measures
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Secondary Outcome Measures
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.
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.
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]
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.
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03626883
Brief Title
Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction
Acronym
1vs2ham
Official Title
Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rafał Kamiński
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 hamstring
Arm Type
Experimental
Arm Description
Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.
Arm Title
2 hamstrings
Arm Type
Active Comparator
Arm Description
Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.
Intervention Type
Procedure
Intervention Name(s)
single-bundle, single-hamstring ACL reconstruction
Intervention Description
anterior cruciate ligament reconstruction with single hamstring tendon
Intervention Type
Procedure
Intervention Name(s)
single-bundle, double-hamstring ACL reconstruction
Intervention Description
anterior cruciate ligament reconstruction with 2 hamstring tendons
Primary Outcome Measure Information:
Title
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
Time Frame
up to 5yrs
Secondary Outcome Measure Information:
Title
Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks
Description
Anderson, AF. Rating scales. In: Fu, FH.; Harner, CD.; Vince, KL., editors. Knee surgery.
Baltimore: Williams & Wilkins; 1994. p. 275-96.
Time Frame
up to 5yrs
Title
Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs
Description
Knee injury and Osteoarthritis Outcome Score minimum score:0, maximum score:100 Baltimore: Williams & Wilkins; 1994. p. 275-96.
Time Frame
up to 5yrs
Title
Change from baseline Lysholm Knee Questionnaire at 104 weeks
Description
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]
Time Frame
up to 5yrs
Title
Change from baseline Visual Analog Scale for Pain at 104 weeks
Description
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.
Time Frame
up to 5yrs
Title
Change from baseline tunnel volume at 104 weeks
Description
Change from baseline tunnel volume will be calculated on magnetic resonance imaging images at 104 weeks postoperatively
Time Frame
104-weeks postop
Title
Change from baseline tunnel diameter at 104 weeks
Description
Change from baseline tunnel diameter will be calculated on standing knee x-rays at 104 weeks postoperatively
Time Frame
104-weeks postop
Title
Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks
Description
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.
Time Frame
up to 5yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
Exclusion Criteria:
revision anterior cruciate ligament surgery
other lower limb injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin K Wasko, M.D., Ph.D.
Organizational Affiliation
Centre for Postgraduate Medical Education in Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education
City
Otwock
State/Province
Woj. Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
12. IPD Sharing Statement
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Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction
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