Deficiency of Anterior Cruciate Ligament
Conditions
Keywords
ACL, BIOSURE, HEALICOIL, PEEK, In-Growth
Brief 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.
Detailed 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.
Interventions
DEVICEBIOSURE™ HEALICOIL™ PK Interference Screw
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone In-growth measured by CT scans | 1 year | Bone In-growth measured by CT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone In-growth measured by CT scans | 6 months | Bone In-growth measured by CT scans |
| 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 | — |
Outcome results
None listed