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Anterior Cruciate Ligament Radiology Follow-up Study

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ClinicalTrials.gov Identifier: NCT02816606
Recruitment Status : Unknown
Verified May 2016 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Brief Summary:
Following recent advances in the understanding of successful anterior cruciate ligament (ACL) reconstruction, three important factors have been identified: femoral tunnel positioning, femoral tunnel aperture shape, and native remnant preservation. Accordingly, the researchers have adapted their technique to address these goals. This study is designed to assess the feasibility of evaluating these graft characteristics, on post-operative imaging, and the ability to show potential improvements with the researchers' technical changes. The study plans to use three-dimensional computer tomography (3D-CT) and magnetic resonance imaging (MRI) to assess these properties and the integration of the graft. In addition, the researchers will use their routine functional scores to monitor the patients' outcome. If successful, the research team hope to set-up a randomised control trial of this alternative technique versus conventional methods with assessment through the same imaging mediums and clinical follow-up.

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Rupture Procedure: Flexible reamers Procedure: 70-degree arthroscope

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiological Follow-up of Alternative ACL Reconstruction Technique
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard Reconstruction Technique
ACL reconstruction using hamstring autograft Using 30-degree arthroscope Using rigid femoral tunnel reamer (Rigid Reamers)
Alternative Reconstruction Group
ACL reconstruction using hamstring autograft Using 30-degree and 70-degree arthroscopes Using flexible femoral tunnel reamer (Flexible Reamers)
Procedure: Flexible reamers
These reamers allow creation of the femoral tunnel to be made in reduced knee flexion and potentially maximise tunnel length

Procedure: 70-degree arthroscope
Using this arthroscope (rather than the more traditional 30-degree) gives improved visualisation of the femoral and tibial footprints. This may translate into better positioning of the tunnel within these regions




Primary Outcome Measures :
  1. Anterior Cruciate Ligament Reconstruction Integrity [ Time Frame: 12 months post-operative ]
    Assessed clinically and using MRI at 12 months post-operative


Secondary Outcome Measures :
  1. Reamer size used for tibial and femoral tunnels [ Time Frame: Intraoperative ]
    Reamer size in mm

  2. Length of femoral tunnel [ Time Frame: Intraoperative ]
    Length in mm - using arthroscopic ruler

  3. Width of femoral tunnel [ Time Frame: Intraoperative ]
    Width in mm - using arthroscopic ruler

  4. Presence of Tibial Stump [ Time Frame: Intraoperative ]
    Present or Absent

  5. Dimensions of Femoral Tunnel [ Time Frame: 3 months post-operative ]
    Measured on CT scan (in mm)

  6. Aperture dimensions in femur [ Time Frame: 3 months post-operative ]
    Measured on CT scan (in mm)

  7. Position of femoral tunnel [ Time Frame: 3 months post-operative ]
    Defined on 3-dimensional reconstruction of CT using grid-method

  8. Revascularisation and healing of ACL graft [ Time Frame: 3 months post-operative ]
    Assessed on MRI scan with signal comparison to posterior cruciate ligament

  9. Revascularisation and healing of ACL graft [ Time Frame: 12 months post-operative ]
    Assessed on MRI scan with signal comparison to posterior cruciate ligament



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Anterior Cruciate Ligament rupture patients with clinical instability
Criteria

Inclusion Criteria:

  • All patients (Aged 18-50) undergoing ACL reconstruction in our unit

Exclusion Criteria:

  • Age under 18 years
  • Patient refusal following informed consent process
  • Inability to undergo post-operative imaging (non-attendance, metal in body preventing MRI, pregnancy preventing CT)
  • Different reconstruction technique chosen for clinical reasons.
  • Revision procedures
  • Previous surgery to the knee (or injury) that may affect the anatomy defined.

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): NCT02816606


Contacts
Contact: Vipul Mandalia 01392 403501
Contact: Elizabeth Gordon rde-tr.research@nhs.net

Locations
United Kingdom
Royal Devon and Exeter Hospital Active, not recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
Principal Investigator: Vipul Mandalia, MBBS Royal Devon and Exeter NHS Foundation Trust

Publications of Results:

Other Publications:
Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02816606     History of Changes
Other Study ID Numbers: 1610321
16/SW/0080 ( Other Identifier: South West Research Ethics Committee )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dissemination in presentations at national meetings and publication in peer-reviewed journal

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
ACL reconstruction

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