Trial Outcomes & Findings for Bone Tunnel Widening Following ACL Reconstruction (NCT NCT00198042)

NCT ID: NCT00198042

Last Updated: 2017-05-17

Results Overview

Bone tunnel diameter measured on MRI

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-05-17

Participant Flow

Patients were recruited from one surgeons practice.

Participant milestones

Measure	Patients Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bone Tunnel Widening Following ACL Reconstruction

Baseline characteristics by cohort

Measure	Patients n=18 Participants Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 age, years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: MRI measurement of tunnel dimensions.

Bone tunnel diameter measured on MRI

Outcome measures

Measure	All Patients n=18 Participants Tunnel expansion after ACL-R occurs early and primarily at the tunnel apertures. Expansion may not affect clinical outcome. Younger age, male sex, and delay from injury to ACL-R may be potential risks for enlargement.
Bone Tunnel Diameter	14.4 mm Standard Deviation 3.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott Rodeo, MD

Hospital for Special Surgery

Phone: 212-606-1000

Email: rodeos@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place