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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.
This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calaxo | Received Calaxo screw | ||
| Milagro | Received a Milagro screw |
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| Measure | Description | Time Frame |
|---|---|---|
| Screw integrity | 2-4 yrs | |
| Tunnel enlargement | 2-4 years |
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Inclusion Criteria:
Exclusion Criteria:
Age: <12 or >35 years of age
Non-active or unable to participate for health reasons
Simultaneous bilateral ACL reconstruction surgeries.
If any of the following conditions exist in the ipsilateral knee:
If any of the following conditions exist in the contralateral knee:
Insufficient initial documentation
Cannot be contacted by phone
Neither Calaxo nor Milagro screw used at the time of ACL reconstruction
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Patients 2-4 years post ACL reconstruction performed by Dr. Kurt Spindler, under age 35, injured in sport, unilateral primary ACL.
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| Name | Affiliation | Role |
|---|---|---|
| Kurt P Spindler, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8774 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24500587 | Result | Cox CL, Spindler KP, Leonard JP, Morris BJ, Dunn WR, Reinke EK. Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study. J Bone Joint Surg Am. 2014 Feb 5;96(3):244-50. doi: 10.2106/JBJS.L.01652. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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