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Clinical Follow-up After ACL Reconstruction (Howell)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607437
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eivind Inderhaug, Bergen Knee Group
  Purpose
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
Deficiency of Anterior Cruciate Ligament Injury of Anterior Cruciate Ligament

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 10-year Follow-up After ACL Reconstruction With Howells Guide, Transtibial Drilling and Hamstrings Graft

Further study details as provided by Eivind Inderhaug, Bergen Knee Group:

Primary Outcome Measures:
  • Revision surgery [ Time Frame: 10 years ]
    When patients have had a new ACL reconstruction of the ACL


Enrollment: 96
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients reconstructed with Howells guide, hamstrings graft and transtibial drilling at Haraldsplass Deaconess Hospital from 1999 to 2001.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607437


Locations
Norway
Haraldsplass Deaconess Hospital
Bergen, Norway
Sponsors and Collaborators
Bergen Knee Group
Investigators
Principal Investigator: Eivind Inderhaug, MD Bergen Knee Group
  More Information

Responsible Party: Eivind Inderhaug, Medical Doctor, Bergen Knee Group
ClinicalTrials.gov Identifier: NCT01607437     History of Changes
Other Study ID Numbers: HowellFollowUp
First Submitted: May 25, 2012
First Posted: May 30, 2012
Last Update Posted: May 30, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries