NCT01607437

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

May 25, 2012

Last Update Submit

May 29, 2012

Conditions

Deficiency of Anterior Cruciate LigamentInjury of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Revision surgery

    When patients have had a new ACL reconstruction of the ACL

    10 years

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients reconstructed with Howells guide, hamstrings graft and transtibial drilling at Haraldsplass Deaconess Hospital from 1999 to 2001.

You may qualify if:

  • \- Patients reconstructed with the given technique

You may not qualify if:

  • Patients reconstructed with other techniques
  • Concomitant ligamental surgery
  • Bilateral ACL injury
  • Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haraldsplass Deaconess Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Eivind Inderhaug, MD

    Bergen Knee Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 25, 2012

First Posted

May 30, 2012

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

NO(1)