Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01069588

Enrollment

Registered

2010-02-17

Start date

2009-12-31

Completion date

2012-04-30

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

bioabsorbable screw, acl reconstruction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Screw integrity	2-4 yrs
Tunnel enlargement	2-4 years

Countries

United States

Outcome results