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Clinical Follow-up After ACL Reconstruction (Howell)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eivind Inderhaug, Bergen Knee Group
ClinicalTrials.gov Identifier:
NCT01607437
First received: May 25, 2012
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bergen Knee Group:

Primary Outcome Measures:
  • Revision surgery [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eivind Inderhaug, Medical Doctor, Bergen Knee Group
ClinicalTrials.gov Identifier: NCT01607437     History of Changes
Other Study ID Numbers: HowellFollowUp
Study First Received: May 25, 2012
Last Updated: May 29, 2012
Health Authority: Norway: Regional Ethics Commitee

ClinicalTrials.gov processed this record on May 22, 2013