Overview

This trial is active, not recruiting.

Condition deficiency of anterior cruciate ligament
Treatment biosure™ healicoil™ pk interference screw
Sponsor Smith & Nephew, Inc.
Start date September 2014
End date March 2017
Trial size 12 participants
Trial identifier NCT02382341, 15000946

Summary

The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as measured by CT scans. Patients' improvement in pain and function will also be followed through various outcome measures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
BIOSURE™ HEALICOIL™ PK Interference Screw
biosure™ healicoil™ pk interference screw
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw

Primary Outcomes

Measure
Bone In-growth measured by CT scans
time frame: 1 year

Secondary Outcomes

Measure
Bone In-growth measured by CT scans
time frame: 6 months
Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively
time frame: 1 year
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively
time frame: 1 year
Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively
time frame: 2 years
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively
time frame: 2 Years

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - ACL tear requiring surgical reconstruction with semitendinosus/gracilis graft. - Willing and able to give voluntary informed consent to participate in this study - Willing and able, in the opinion of the investigator, to cooperate with study procedures and willing to return to study site for all post-operative study visits. - Subject is between 18 and 50 years at the time of surgery - ASA group 0-2 (limited medical illness). Exclusion Criteria: - Revision ACL reconstruction - Cartilage injury (IKDC Grade IV lesion> 2 cm2) - Current malignant disease - Rheumatoid arthritis - Osteonecrosis or Avascular Necrosis - Ankylosing spondylitis - Subject is Obese; BMI > 35 - Subject is pregnant or plans to become pregnant during the study - Subject has received medical treatment within 6 weeks of enrollment with any of the following: Glucocorticoids Growth hormone - Participating in another investigational trial or on-going study that would interfere with the assessment of the primary and secondary outcomes

Additional Information

Official title A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation
Principal investigator Martin Lind, MD, PhD
Description The primary objective of the current study is to assess bone in-growth in the BIOSURE™ HEALICOIL™ Interference screw in the tibial tunnel of patients undergoing ACL reconstruction with soft tissue grafts; tunnel widening and change in IKDC knee and subjective scores will also be documented.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..