Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069588
• Other study ID #: 090805
• Status: Completed
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.

Description:

This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age range: 12-35 years of age at the time of follow-up.

• Gender: Both.

• Minorities: All.

• Involved in sports at the time of injury.

• Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery

• Bioabsorbable Screws used during ACL reconstruction surgery

Exclusion Criteria:

• Age: <12 or >35 years of age

• Non-active or unable to participate for health reasons

• Simultaneous bilateral ACL reconstruction surgeries.

• If any of the following conditions exist in the ipsilateral knee:

• Revision ACL reconstruction

• Complex knee injury

• If any of the following conditions exist in the contralateral knee:

• ACL deficient

• Prior ACL reconstruction

• Prior surgery of any type

• Insufficient initial documentation

• Cannot be contacted by phone

• Neither Calaxo nor Milagro screw used at the time of ACL reconstruction

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study. J Bone Joint Surg Am. 2014 Feb 5;96(3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screw integrity		2-4 yrs
Primary	Tunnel enlargement		2-4 years