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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.
The primary objective of the current study is to assess bone in-growth in the BIOSUREâ„¢ HEALICOILâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | BIOSUREâ„¢ HEALICOILâ„¢ PK Interference Screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOSUREâ„¢ HEALICOILâ„¢ PK Interference Screw | Device | Subjects will receive the appropriate sized BIOSUREâ„¢ HEALICOILâ„¢ PK Interference Screw |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone In-growth measured by CT scans | Bone In-growth measured by CT scans | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Glucocorticoids Growth hormone
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Patients undergoing ACL reconstruction
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| Name | Affiliation | Role |
|---|---|---|
| Martin Lind, MD, PhD | Aarhus University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32948982 | Derived | Lind M, Nielsen T, Sorensen OG, Mygind-Klavsen B, Fauno P, Leake-Gardner S. Bone ingrowth into open architecture PEEK interference screw after ACL reconstruction. J Exp Orthop. 2020 Sep 18;7(1):68. doi: 10.1186/s40634-020-00285-z. |
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| 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 |