Anterior Cruciate Ligament (ACL) Tunnel Widening Comparing All-inside and Interference Screw Fixation Technique
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|ClinicalTrials.gov Identifier: NCT02052856|
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : September 26, 2014
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|Condition or disease|
|Anterior Cruciate Ligament Injury Knee Injury ACL Injury|
- 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.
- 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.
- 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.
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Interference Screw Fixation Versus All-Inside Suspensory Fixation Method Comparing Radiographic Tunnel Widening in Anatomic Single Bundle Anterior Cruciate Ligament (ACL) Reconstruction.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||May 2014|
All English speaking patients 16 years and older having anterior cruciate ligament (ACL) surgery without any other surgery to knee or contralateral knee.
- Tunnel Widening [ Time Frame: 1-2 years postoperatively ]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.
- Secondary outcomes will include clinical assessment for anterior cruciate ligament stability. [ Time Frame: 1-2 years postoperatively ]
Clinical assessment will include:
Amount of anterior tibial translation relative to contralateral knee and Lachmans test.
- Quality of Life secondary outcome measures [ Time Frame: 1-2 years postoperatively ]Anterior cruciate ligament Quality of life, Lysholm and International Knee Documentation Committee Score (IKDC)
- Knee ligament Arthrometry (KT-1000 Arthrometry) [ Time Frame: 1-2 years postoperatively ]The laxity of knee will be measured with knee ligament arthrometry (KT-1000 Arthrometry) to test for stability.
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- 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
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): NCT02052856
|Canada, British Columbia|
|Joint Preservation Centre of BC ( University of British Columbia Hospital)|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Principal Investigator:||Patrick Chin, MD, FRCS(C),||Joint Preservation Centre of BC|
|Responsible Party:||University of British Columbia|
|Other Study ID Numbers:||
|First Posted:||February 3, 2014 Key Record Dates|
|Last Update Posted:||September 26, 2014|
|Last Verified:||September 2014|
All-Inside Suspensory Method
Biointerference Screw Fixation
Wounds and Injuries
Anterior Cruciate Ligament Injuries