BIOSUREâ„¢ HEALICOILâ„¢ PK Bone In-growth Study (NCT02382341) | Clinical Trial Compass
CompletedNot Applicable
BIOSUREâ„¢ HEALICOILâ„¢ PK Bone In-growth Study
12 participantsStarted 2014-09-12
Plain-language summary
The study seeks to document the bone in-growth into the BIOSUREâ„¢ HEALICOIL PK screw as measured by CT scans. Patients' improvement in pain and function will also be followed through various outcome measures.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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