BIOSURE™ HEALICOIL™ PK Bone In-growth Study

Smith & Nephew, Inc.12 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Deficiency of Anterior Cruciate Ligament

Interventions

BIOSURE™ HEALICOIL™ PK Interference ScrewDEVICE

Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bone In-growth measured by CT scans

Time frame: 1 year

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.