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Anterior Cruciate Ligament InjuryNCT02052856

Anterior Cruciate Ligament (ACL) Tunnel Widening Comparing All-inside and Interference Screw Fixation Technique

An observational study of Anterior Cruciate Ligament Injury and Knee Injury, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the incidence and degree of bone tunnel widening between two groups who have undergone anterior cruciate ligament reconstructive surgery. Read more about this study

Who is it for?
Ages 16 years and older
How many people
40 participants
Where
1 siteCanada
Study dates
Dec 2012to May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All anterior cruciate ligament (ACL) surgeries performed at the Joint Preservation Centre of BC from November/2012 to present

Who may be able to join

  • age greater than 16 years old
  • unilateral anterior cruciate ligament (ACL) rupture
  • normal contralateral knee
  • English speaking subjects
  • subjects who are a minimum of 1 to 2 years post operative

Who cannot join

  • additional ligament injury greater than grade II
  • history of previous knee surgery ( Partial Medial Meniscectomy is included)
  • mechanical or anatomic malalignment
  • Outerbridge grade 3 or 4 arthritic changes
  • English as a second language (ESL) subjects
  • Pregnant women or women intending to get pregnant

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Joint Preservation Centre of BC ( University of British Columbia Hospital)

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

Official title: Interference Screw Fixation Versus All-Inside Suspensory Fixation Method Comparing Radiographic Tunnel Widening in Anatomic Single Bundle Anterior Cruciate Ligament (ACL) Reconstruction.

The purpose of this study is to evaluate the incidence and degree of bone tunnel widening between two groups who have undergone anterior cruciate ligament reconstructive surgery. The two groups have undergone different graft fixation methods: an interference screw/suspensory button fixation hybrid technique, and an all-inside suspensory method fixation. Tunnels are created at the time of surgery for graft placement and fixation, but have been known to enlarge post-operatively. Little has been studied on the relatively new all-inside technique. X-rays of the operative knee will be used to assess tunnel width. Secondary outcomes will include clinical evaluation and outcome scoring questionnaires

Read the detailed description
  1. Purpose The purpose of this study is to compare a cohort of patients who have undergone anterior cruciate ligament (ACL) reconstructive surgery performed using either an interference screw fixation and suspensory button fixation hybrid technique, with another cohort of patients who have undergone an all-inside suspensory method fixation. We plan to evaluate the incidence and degree of bone tunnel widening between the two groups. This will consist of two x-rays of the operative knee in both the anteroposterior and lateral view, at a 1 to 2 year follow-up.
  2. Hypothesis Our hypothesis is that the all-inside technique using suspensory button fixation will result in less tunnel widening compared to a hybrid technique using interference screw and suspensory button fixation. With the all-inside technique using the anatomic anterior cruciate ligament (ACL) position there will be less potential for a "bungee-cord effect" and "windshield-wiper effect" as previously seen with more vertical transtibial tunnel techniques. Using this technique, shorter tunnels and closer fixation points will result in less graft motion to cause tunnel widening. This is in contrast to interference screw technique which we feel will enlarge tunnel size mechanically upon insertion.
  3. Justification There have been many described techniques for anterior cruciate ligament (ACL) reconstruction surgery. This include graft options, tunnel positioning and fixation methods. Over the last few years, the placement of both femoral and tibial tunnels has evolved from an isometric position to a more anatomic position. The fixation methods can vary from interference screw fixation, suspensory button fixation and a trans-fix pin fixation. What we have seen in the isometric tunnel positions is the issue of tunnel widening. This has been associated with graft failure and increased knee laxity. Tunnel widening can also lead to insufficient bone stock complicating revision surgery and potentially requiring a 2-stage procedure with bone grafting. Tunnel widening has been shown with both interference screw and endobutton fixation in the past. More recently, newer instrumentation and an all-inside technique have been utilized at our institution that has some potential benefits including prevention of tunnel widening.
  4. Objectives The primary outcome for this study will be radiographic assessment of tunnel width on both the femoral and tibial tunnels. X-rays will be taken in both the anteroposterior and lateral views to assess tunnel width. X-rays will be taken at 1 to 2 year follow-up following surgery. Tunnel width will be measured perpendicular to the the tunnels based on the sclerotic margins. 3 separate measurements, spaced 5 mm apart, will be taken in both the AP and lateral views. The centre of these measurements will be based at the location of the greatest width. An average of these measurements will be calculated and used to calculate bone tunnel enlargement.
  5. Research Methods We plan to review the last 60 patients who have undergone anterior cruciate ligament (ACL) reconstructive surgery (30 in each study arm) performed with either technique by 3 orthopedic surgeons with subspecialty training in arthroscopic knee surgery who use similar techniques. All surgeries were performed at one center from November 2012 until present.

All patients who have had anterior cruciate ligament (ACL) surgery at our institution have been entered into a data registry that includes: patient demographics and anterior cruciate ligament Quality of life outcome scores. We plan to analyze this data including surgical data on graft and tunnel sizes, fixation methods and post-operative radiographs. Post-operative radiographs will be taken at one to two year follow-up to assess tunnel width. Clinical assessment, knee ligament arthrometry (KT-1000) measurements, and outcome measure scores, anterior cruciate ligament (Quality of Life) , Lysholm and International Knee Documentation Committee (IKDC) will also be taken during each visit. Written, informed consent will be obtained from each patient prior to entering them into the study.

Keywords
Tunnel Widening, All-Inside Suspensory Method, Biointerference Screw Fixation
Medical subject headings
Anterior Cruciate Ligament Injuries, Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02052856
Study groupRoleWhat they receive
ACL SurgeryAll English speaking patients 16 years and older having anterior cruciate ligament (ACL) surgery without any other surgery to knee or contralateral knee.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tunnel Widening

    The primary outcome for this study will be radiographic assessment of tunnel width on both the femoral and tibial tunnels. X-rays will be taken in both the anteroposterior and lateral views to assess tunnel width. X-rays will be taken at 1 to 2 year follow-up. Tunnel width will be measured perpendicular to the tunnels based on the sclerotic margins. 3 separate measurements, spaced 5 mm apart, will be taken in both the anteroposterior and lateral views. The centre of these measurements will be based at the location of the greatest width. An average of these measurements will be calculated and used to calculate bone tunnel enlargement.

    Measured: 1-2 years postoperatively

Secondary outcomes (1)
  1. Secondary outcomes will include clinical assessment for anterior cruciate ligament stability.

    Clinical assessment will include:

    Amount of anterior tibial translation relative to contralateral knee and Lachmans test.

    Measured: 1-2 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startDec 2012
  3. Primary completionFeb 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052856
Sponsor's protocol ID
H12-03439
Status last verified
Sep 2014
First submitted
27 Jan 2014
Last updated
26 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Sabat D, Kundu K, Arora S, Kumar V. Tunnel widening after anterior cruciate ligament reconstruction: a prospective randomized computed tomography--based study comparing 2 different femoral fixation methods for hamstring graft. Arthroscopy. 2011 Jun;27(6):776-83. doi: 10.1016/j.arthro.2011.02.009.

    PubMed 21624672

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injury and Knee Injury, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tunnel Widening (time frame: 1-2 years postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02052856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2014.

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