NCT02680821

Brief Summary

Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient reported outcome measure (PROM) scores compared to patients, who have ACL revision surgery without ALL reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

8.6 years

First QC Date

February 8, 2016

Last Update Submit

September 30, 2025

Conditions

Rupture of Anterior Cruciate LigamentAnterolateral Ligament Reconstruction

Keywords

LaxityKneeRuptureALL

Outcome Measures

Primary Outcomes (1)

  • Difference in The Knee Numeric-Entity Evaluation Score (KNEES)

    questionaire

    12 months

Secondary Outcomes (3)

  • Difference in Knee injury and Osteoarthritis Outcome Score (KOOS)

    12 Months

  • Difference in KT-1000

    12 Months

  • Difference in TEGNER functional score

    12 Months

Study Arms (2)

Isolated ACL-revision

OTHER

The standard operation with an isolated Anterior cruciate ligament.

Procedure: ACL revision (Anterior cruciate ligament )

Combined ACL and ALL surgery

OTHER

An operation with an Anterior cruciate ligament combined with an anterolateral ligament.

Procedure: ALL reconstruction (Anterolateral ligament)Procedure: ACL revision (Anterior cruciate ligament )

Interventions

ALL reconstruction (Anterolateral ligament)PROCEDURE
Combined ACL and ALL surgery
ACL revision (Anterior cruciate ligament )PROCEDURE
Combined ACL and ALL surgeryIsolated ACL-revision

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with ACL revision surgery indication

You may not qualify if:

  • Patients with difficulties of understanding danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Trauma, Tage-Hansens Gade 2b

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesRupture

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations

DK(1)