NCT03841500

Brief Summary

The purpose of our study was to compare osseous integration of the bone block in Achilles tendon allograft ACL reconstruction using a cortical button versus biocomposite interference screw fixation. The primary outcome was bone block incorporation within the femoral tunnel at six months. Our null hypothesis was that there is no difference in osseous incorporation or outcome with either type of femoral fixation in primary ACL reconstruction with Achilles tendon allograft. Our secondary outcomes were pain and clinical outcome scores between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 7, 2019

Last Update Submit

February 14, 2019

Conditions

ACL - Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

  • Femoral Ossification Score

    Amount of ossification (osseous integration) around the graft at 6 months post-operatively as seen on CT scan. Score range: 0 (minimum) - 5 (maximum). Score of 0 is the worst outcome and indicates no ossification in the femoral tunnel as seen on CT scan. Score of 5 indicates full ossification of the tunnel (best outcome) as seen on CT scan. Scores in between indicate partial ossification (each number 20% more ossification than the previous score).

    6 months post-op

Secondary Outcomes (3)

  • Pain (VAS)

    Obtained preoperatively (right before surgery); 2 weeks after surgery; and 6 months after surgery

  • Knee range of motion

    Obtained preoperatively (right before surgery) and at 6 months after surgery

  • International Knee Documentation Committee (IKDC) subjective knee score

    Obtained preoperatively (right before surgery) and at 6 months after surgery

Study Arms (2)

Aperture (biocomposite screw) fixation

ACTIVE COMPARATOR

16 patients in this arm underwent ACL reconstruction with the allograft fixed in the femoral tunnel with a biocomposite interference screw (BioComposite Screw, Arthrex, North Naples, FL; or MILAGRO screw, DePuy Mitek, Raynham, MA, USA). Intervention: ACL reconstruction with the allograft fixed in the femoral tunnel with a biocomposite interference screw.

Device: Biocomposite intereference screw femoral tunnel fixation

Suspensory (endobutton) fixation

ACTIVE COMPARATOR

17 patients in this arm underwent ACL reconstruction with the allograft secured in the femoral tunnel with a cortical button (TightRope, Arthrex, North Naples, FL, USA). Intervention: ACL reconstruction with the allograft secured in the femoral tunnel with a cortical button.

Device: Endobutton (Tightrope) femoral tunnel fixation

Interventions

Biocomposite intereference screw femoral tunnel fixationDEVICE

ACL reconstruction using biocomposite intereference screw for femoral tunnel fixation

Aperture (biocomposite screw) fixation
Endobutton (Tightrope) femoral tunnel fixationDEVICE

ACL reconstruction using endobutton (Tightrope) for femoral tunnel fixation

Suspensory (endobutton) fixation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients between the ages of 18 and 50 able to provide informed consent with ACL tears meeting the indications for reconstruction and electing to undergo reconstruction with an Achilles tendon allograft.

You may not qualify if:

  • History of prior ACL reconstruction
  • pregnancy
  • inflammatory disease
  • a primary bone disorder
  • those taking bone resorption inhibitor medications
  • those with injuries to the collateral ligaments or posterior cruciate ligament

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelsey-Seybold Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Anup Shah

    Kelsey-Seybold Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 15, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

Primary and secondary outcome measures (de-identified)

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data is already available (study has been completed)
Access Criteria
Standard

Locations

US(1)