NCT03626883

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

4.2 years

First QC Date

February 13, 2018

Last Update Submit

February 3, 2022

Conditions

Anterior Cruciate Ligament Injury

Keywords

arthroscopy

Outcome Measures

Primary Outcomes (1)

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

    up to 5yrs

Secondary Outcomes (7)

  • 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 Lysholm Knee Questionnaire at 104 weeks

    up to 5yrs

  • Change from baseline Visual Analog Scale for Pain at 104 weeks

    up to 5yrs

  • Change from baseline tunnel volume at 104 weeks

    104-weeks postop

  • +2 more secondary outcomes

Study Arms (2)

1 hamstring

EXPERIMENTAL

Patients will receive the intervention of 'single-bundle, single-hamstring ACL reconstruction'.

Procedure: single-bundle, single-hamstring ACL reconstruction

2 hamstrings

ACTIVE COMPARATOR

Patients will receive the intervention of 'single-bundle, double-hamstring ACL reconstruction'.

Procedure: single-bundle, double-hamstring ACL reconstruction

Interventions

single-bundle, single-hamstring ACL reconstructionPROCEDURE

anterior cruciate ligament reconstruction with single hamstring tendon

1 hamstring
single-bundle, double-hamstring ACL reconstructionPROCEDURE

anterior cruciate ligament reconstruction with 2 hamstring tendons

2 hamstrings

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • revision anterior cruciate ligament surgery
  • other lower limb injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. A. Gruca Teaching Hospital, Centre for Postgraduate Medical Education

Otwock, Woj. Mazowieckie, 05-400, Poland

Location

Related Publications (1)

  • Kulinski K, Wasko MK, Trams E, Malesa K, Pomianowski S, Kaminski R. Anterior Cruciate Ligament Reconstruction Using a 4-Strand Semitendinosus Tendon Graft or a Doubled Semitendinosus and Gracilis Tendon Graft: A 4.5-Year Prospective, Randomized, Double-Blind, Parallel-Group Study. Am J Sports Med. 2023 Mar;51(3):615-626. doi: 10.1177/03635465221149738.

    PMID: 36856280DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Marcin K Wasko, M.D., Ph.D.

    Centre for Postgraduate Medical Education in Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 13, 2018

First Posted

August 13, 2018

Study Start

December 1, 2015

Primary Completion

January 30, 2020

Study Completion

July 30, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations

PL(1)