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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

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring arthroscopy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

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

NCT ID

NCT03626883

First Posted

February 13, 2018

Last Updated

February 3, 2022

Sponsor

Rafał Kamiński

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Time Frame

up to 5yrs

Title

Change from baseline Visual Analog Scale for Pain at 104 weeks

Description

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

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

Learn more about this trial

Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction

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