## Protocol Section
### Identification Module
**NCT ID:** NCT02993679

**Brief Title:** Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction

**Official Title:** Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study

#### Organization Study ID Info
**ID:** Hospital Znojmo
#### Organization
**Class:** OTHER
**Full Name:** Hospital Znojmo
### Status Module
#### Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-12-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-07

**Type:** ACTUAL

#### Start Date
**Date:** 2014-07

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2016-12-15
**Type:** ESTIMATED
**Study First Submit Date:** 2016-12-04
**Study First Submit QC Date:** 2016-12-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Znojmo

#### Responsible Party

**Investigator Affiliation:** Hospital Znojmo

**Investigator Full Name:** Komzak Martin, M.D.

**Investigator Title:** General Hospital Znojmo

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Cruciate Ligament Rupture

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** surgical reconstruction of the anterior cruciate ligament

**Intervention Names:**

- Procedure: reconstruction of the ACL and anterolateral ligament

**Label:** double-bundle ACL reconstruction

**Type:** OTHER

#### Arm Group 2

**Description:** surgical reconstruction of the anterolateral ligament

**Intervention Names:**

- Procedure: reconstruction of the ACL and anterolateral ligament

**Label:** anterolateral ligament reconstruction

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- anterolateral ligament reconstruction

- double-bundle ACL reconstruction

**Description:** reconstruction of the ACL and anterolateral ligament

**Name:** reconstruction of the ACL and anterolateral ligament

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

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

**Time Frame:** 24 months after the operation

### Eligibility Module

**Eligibility Criteria:** 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:

* Associated injuries of the tissue around the knee joint

**Maximum Age:** 40 Years

**Minimum Age:** 17 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: HIGH

- As Found: Rupture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012421

- Term: Rupture

### Misc Info Module

- Version Holder: 2024-05-24
