NCT02816606

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 1, 2019

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

June 15, 2016

Last Update Submit

February 27, 2019

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACL reconstruction

Outcome Measures

Primary Outcomes (1)

  • Anterior Cruciate Ligament Reconstruction Integrity

    Assessed clinically and using MRI at 12 months post-operative

    12 months post-operative

Secondary Outcomes (9)

  • Reamer size used for tibial and femoral tunnels

    Intraoperative

  • Length of femoral tunnel

    Intraoperative

  • Width of femoral tunnel

    Intraoperative

  • Presence of Tibial Stump

    Intraoperative

  • Dimensions of Femoral Tunnel

    3 months post-operative

  • +4 more secondary outcomes

Study Arms (2)

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 reamersProcedure: 70-degree arthroscope

Interventions

Flexible reamersPROCEDURE

These reamers allow creation of the femoral tunnel to be made in reduced knee flexion and potentially maximise tunnel length

Alternative Reconstruction Group
70-degree arthroscopePROCEDURE

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

Alternative Reconstruction Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Anterior Cruciate Ligament rupture patients with clinical instability

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Devon and Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

Related Publications (12)

  • Bucher TA, Naim S, Mandalia V. The use of the 70 degrees arthroscope for anatomic femoral and tibial tunnel placement and tunnel viewing in anterior cruciate ligament reconstruction. Arthrosc Tech. 2014 Jan 3;3(1):e79-81. doi: 10.1016/j.eats.2013.08.001. eCollection 2014 Feb.

    PMID: 24749046BACKGROUND

  • Rasmussen JF, Lavery KP, Dhawan A. Anatomic anterior cruciate ligament reconstruction with a flexible reamer system and 70 degrees arthroscope. Arthrosc Tech. 2013 Aug 30;2(4):e319-22. doi: 10.1016/j.eats.2013.04.003. eCollection 2013.

    PMID: 24400174BACKGROUND

  • Hosseini A, Lodhia P, Van de Velde SK, Asnis PD, Zarins B, Gill TJ, Li G. Tunnel position and graft orientation in failed anterior cruciate ligament reconstruction: a clinical and imaging analysis. Int Orthop. 2012 Apr;36(4):845-52. doi: 10.1007/s00264-011-1333-4. Epub 2011 Aug 9.

    PMID: 21826407RESULT

  • Tompkins M, Milewski MD, Carson EW, Brockmeier SF, Hamann JC, Hart JM, Miller MD. Femoral tunnel length in primary anterior cruciate ligament reconstruction using an accessory medial portal. Arthroscopy. 2013 Feb;29(2):238-43. doi: 10.1016/j.arthro.2012.08.019. Epub 2012 Dec 24.

    PMID: 23270787RESULT

  • Brown CH Jr, Spalding T, Robb C. Medial portal technique for single-bundle anatomical anterior cruciate ligament (ACL) reconstruction. Int Orthop. 2013 Feb;37(2):253-69. doi: 10.1007/s00264-012-1772-6. Epub 2013 Jan 20.

    PMID: 23334708RESULT

  • Gohil S, Annear PO, Breidahl W. Anterior cruciate ligament reconstruction using autologous double hamstrings: a comparison of standard versus minimal debridement techniques using MRI to assess revascularisation. A randomised prospective study with a one-year follow-up. J Bone Joint Surg Br. 2007 Sep;89(9):1165-71. doi: 10.1302/0301-620X.89B9.19339.

    PMID: 17905952RESULT

  • Ahn JH, Lee SH, Choi SH, Lim TK. Magnetic resonance imaging evaluation of anterior cruciate ligament reconstruction using quadrupled hamstring tendon autografts: comparison of remnant bundle preservation and standard technique. Am J Sports Med. 2010 Sep;38(9):1768-77. doi: 10.1177/0363546510368132.

    PMID: 20805412RESULT

  • Hong L, Li X, Zhang H, Liu X, Zhang J, Shen JW, Feng H. Anterior cruciate ligament reconstruction with remnant preservation: a prospective, randomized controlled study. Am J Sports Med. 2012 Dec;40(12):2747-55. doi: 10.1177/0363546512461481. Epub 2012 Oct 17.

    PMID: 23075805RESULT

  • Yang JH, Chang M, Kwak DS, Wang JH. Volume and contact surface area analysis of bony tunnels in single and double bundle anterior cruciate ligament reconstruction using autograft tendons: in vivo three-dimensional imaging analysis. Clin Orthop Surg. 2014 Sep;6(3):290-7. doi: 10.4055/cios.2014.6.3.290. Epub 2014 Aug 5.

    PMID: 25177454RESULT

  • Kim JG, Chang MH, Lim HC, Bae JH, Ahn JH, Wang JH. Computed tomography analysis of the femoral tunnel position and aperture shape of transportal and outside-in ACL reconstruction: do different anatomic reconstruction techniques create similar femoral tunnels? Am J Sports Med. 2013 Nov;41(11):2512-20. doi: 10.1177/0363546513500626. Epub 2013 Aug 27.

    PMID: 23982402RESULT

  • Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654.

    PMID: 20516317RESULT

  • Kosy JD, Walmsley K, Sharma AD, Gordon EA, Heddon SV, Anaspure R, Schranz PJ, Mandalia VI. A comparison of femoral tunnel placement in ACL reconstruction using a 70 degrees arthroscope through the anterolateral portal versus a 30 degrees arthroscope through the anteromedial portal: a pilot 3D-CT study. Knee Surg Relat Res. 2020 Apr 3;32(1):17. doi: 10.1186/s43019-020-00037-4.

    PMID: 32660634DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Vipul Mandalia, MBBS

    Royal Devon and Exeter NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 28, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

August 1, 2019

Last Updated

March 1, 2019

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Dissemination in presentations at national meetings and publication in peer-reviewed journal

Locations

GB(1)