Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

NCT ID: NCT01069588

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-04-30

Brief 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.

Detailed 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.

Conditions

Rupture of Anterior Cruciate Ligament

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Calaxo

Received Calaxo screw

No interventions assigned to this group

Milagro

Received a Milagro screw

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kurt P. Spindler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kurt P Spindler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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):244-50. doi: 10.2106/JBJS.L.01652.

Reference Type: RESULT

PMID: 24500587 (View on PubMed)

Other Identifiers

090805

Identifier Type: -

Identifier Source: org_study_id