Clincosm LogoSign in Get a demo

Howell: Clinical Follow-up After ACL Reconstruction

Sponsor
Bergen Knee Group (Other)
Overall Status
Completed
CT.gov ID
NCT01607437
Collaborator
(none)
96
Enrollment
1
Location
12
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

No former studies have done long-term evaluation on patients reconstructed with hamstrings graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel. The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum of 10 years after surgery. According to former published studies on alike methods, the use of transtibial drilling of the femoral graft tunnel causes an increased rotational instability of the knee. The investigators aim to map the clinical stability of this group as well as evaluating the general outcome at the long-time horizon.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients will be invited to a clinical follow-up with x-ray of the knee, scoring of Lysholm and IKDC subjective scores, clinical examination including instrumented testing with a KT-1000. After informed consent data will be collected from patient records and stored in a secured internal database. Analysis will be done with the SPSS package.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    96 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    10-year Follow-up After ACL Reconstruction With Howells Guide, Transtibial Drilling and Hamstrings Graft
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Revision surgery [10 years]

      When patients have had a new ACL reconstruction of the ACL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients reconstructed with the given technique
    Exclusion Criteria:

    • Patients reconstructed with other techniques

    • Concomitant ligamental surgery

    • Bilateral ACL injury

    • Revision surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haraldsplass Deaconess Hospital Bergen Norway

    Sponsors and Collaborators

    • Bergen Knee Group

    Investigators

    • Principal Investigator: Eivind Inderhaug, MD, Bergen Knee Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eivind Inderhaug, Medical Doctor, Bergen Knee Group
    ClinicalTrials.gov Identifier:
    NCT01607437
    Other Study ID Numbers:
    • HowellFollowUp
    First Posted:
    May 30, 2012
    Last Update Posted:
    May 30, 2012
    Last Verified:
    May 1, 2012
    Additional relevant MeSH terms:
    Anterior Cruciate Ligament Injuries

    Study Results

    No Results Posted as of May 30, 2012