NCT02993679

Brief Summary

The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

December 4, 2016

Last Update Submit

December 14, 2016

Conditions

Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

  • Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.

    Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.

    24 months after the operation

Study Arms (2)

double-bundle ACL reconstruction

OTHER

surgical reconstruction of the anterior cruciate ligament

Procedure: reconstruction of the ACL and anterolateral ligament

anterolateral ligament reconstruction

OTHER

surgical reconstruction of the anterolateral ligament

Procedure: reconstruction of the ACL and anterolateral ligament

Interventions

reconstruction of the ACL and anterolateral ligamentPROCEDURE

reconstruction of the ACL and anterolateral ligament

anterolateral ligament reconstructiondouble-bundle ACL reconstruction

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The isolated ACL lesion
  • The absence of the previous surgery on the knee joint
  • The body mass index (BMI) less than 30.

You may not qualify if:

  • Associated injuries of the tissue around the knee joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Hospital Znojmo

Study Record Dates

First Submitted

December 4, 2016

First Posted

December 15, 2016

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

November 1, 2016

Last Updated

December 15, 2016

Record last verified: 2016-12