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

NCT02052856 | Completed

• 1 other identifier: H12-03439
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Anterior Cruciate Ligament Injury; Knee Injury; ACL Injury

Keywords

Tunnel Widening; All-Inside Suspensory Method; Biointerference Screw Fixation

Outcome Measures

Primary Outcomes (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.

  1-2 years postoperatively

Secondary Outcomes (1)

• Secondary outcomes will include clinical assessment for anterior cruciate ligament stability.

  1-2 years postoperatively

Other Outcomes (2)

• Quality of Life secondary outcome measures

  1-2 years postoperatively

• Knee ligament Arthrometry (KT-1000 Arthrometry)

  1-2 years postoperatively

Study Arms (1)

ACL Surgery

All English speaking patients 16 years and older having anterior cruciate ligament (ACL) surgery without any other surgery to knee or contralateral knee.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Joint Preservation Centre of BC ( University of British Columbia Hospital)

Vancouver, British Columbia, V6T 2B5, Canada

Location

Related Publications (1)

• 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.

  PMID: 21624672 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Patrick Chin, MD, FRCS(C),

  Joint Preservation Centre of BC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 3, 2014
• Study Start: December 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

CA (1)