NCT02450292

Brief Summary

The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

May 18, 2015

Last Update Submit

November 11, 2022

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (1)

  • Screw resorption

    Evaluated on X-ray and CT

    5 years

Interventions

Bioabsorbable screw fixationPROCEDURE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.

You may qualify if:

  • Ages 18-50
  • Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
  • Isolated ACL tear
  • Type of graft used was bone-patellar tendon-bone autograft
  • Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
  • No degenerative joint disease on preoperative X-rays (\> 50% joint space loss, presence of osteophytes)

You may not qualify if:

  • Revision ACL reconstructions
  • Types of grafts other than bone-patellar tendon-bone autograft were used
  • ACL tear with concomitant pathology
  • Degenerative joint disease on preoperative X-ray (\> 50% joint space loss, presence of osteophytes)
  • Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
  • ACL reconstruction performed less than 5 years ago
  • Pregnancy
  • Greater than Grade 2 laxity of other ligaments
  • No additional fixation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Marc Fineberg, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Sports Medicine, Associate Professor of Clinical Orthopaedics

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

November 16, 2022

Record last verified: 2022-11