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CompletedNCT02993679Updated Dec 15, 2016

Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction

An interventional study of reconstruction of the ACL and anterolateral ligament in Cruciate Ligament Rupture, sponsored by Hospital Znojmo. Completed. Open to participants aged 17 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-12-15.

Sponsored by Hospital Znojmo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
17 Years to 40 Years
Sex
All
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Study 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.

Read the detailed description

Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).

There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) 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). (2) To analyse when the ALL is necessary to reconstruct.

Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.

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Conditions studied

  • Cruciate Ligament Rupture

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03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 334 interventional studies indexed under Rupture.

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Lead sponsor

Hospital Znojmo is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Associated injuries of the tissue around the knee joint
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Other
    double-bundle ACL reconstruction

    surgical reconstruction of the anterior cruciate ligament

    Procedure: reconstruction of the ACL and anterolateral ligament

  • Other
    anterolateral ligament reconstruction

    surgical reconstruction of the anterolateral ligament

    Procedure: reconstruction of the ACL and anterolateral ligament

Interventions

  • Procedurereconstruction of the ACL and anterolateral ligament

    reconstruction of the ACL and anterolateral ligament

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What researchers measure

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.

    Time frame: 24 months after the operation

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02993679
Lead sponsor
Hospital Znojmo
Responsible party
Komzak Martin, M.D. (General Hospital Znojmo, Hospital Znojmo) — Principal investigator
First posted
Dec 15, 2016
Start date
Jul 2014
Primary completion
Jul 2016
Completion
Nov 2016
Last update
Dec 15, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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