Clinical Follow-up After ACL Reconstruction

Injury of Anterior Cruciate Ligament Clinical Trial

— Howell  

Official title:

10-year Follow-up After ACL Reconstruction With Howells Guide, Transtibial Drilling and Hamstrings Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607437
• Other study ID #: HowellFollowUp
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: May 29, 2012
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2012
• Source: Bergen Knee Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients reconstructed with the given technique

Exclusion Criteria:

• Patients reconstructed with other techniques

• Concomitant ligamental surgery

• Bilateral ACL injury

• Revision surgery

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Deficiency of Anterior Cruciate Ligament
• Injury of Anterior Cruciate Ligament

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconess Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Bergen Knee Group

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision surgery	When patients have had a new ACL reconstruction of the ACL	10 years	No