BIOSURE™ HEALICOIL™ PK Bone In-growth Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation

Conditions
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Deficiency of Anterior Cruciate Ligament

Intervention / Treatment
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* Device: BIOSURE™ HEALICOIL™ PK Interference Screw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>BIOSURE™ HEALICOIL™ PK Interference Screw | Device: BIOSURE™ HEALICOIL™ PK Interference Screw<br>* Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone In-growth measured by CT scans | Bone In-growth measured by CT scans | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone In-growth measured by CT scans | Bone In-growth measured by CT scans | 6 months | 
| Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively |  | 1 year | 
| Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively |  | 1 year | 
| Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively |  | 2 years | 
| Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, BIOSURE, HEALICOIL, PEEK, In-Growth