BIOSURE™ HEALICOIL™ PK Bone In-growth Study
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
12 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal