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The purpose of the research study is to determine the efficacy and efficiency of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care, L-O (Lew-Omar), suture repair technique. The investigators will also determine if there are similar or different rates of complications and failures via both objective and subjective measures.
To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. The investigators will determine if there are similar or different rates of complications and failures (both intraoperatively and at 2-week, 6-week, 3-month, and 6-month post-operative intervals).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repair with the CoNextions tendon repair device | |||
| repair with a "standard of care" repair technique known as the Lew-Omar (LO) technique |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. Also to determine if there are similar or different rates of complications and failures | From enrollment to end of postoperative follow up at 6-months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Repair | The units measured will be minutes/seconds for repair | From enrollment to end of postoperative follow up at 6-months |
| Visual Analog Pain Scale | Visual number scale to rate pain |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett Lewellyn, MD | Contact | 321-843-5851 | Brett.Lewellyn@orlandohealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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| From enrollment to end of postoperative follow up at 6-months |
| Quick DASH Form | Assessment of symptoms and ability to perform certain activities. | From enrollment to end of postoperative follow up at 6-months |
| Patient Satisfaction Questionnaire | Assessment of perceptions of technical quality, interpersonal manner, communication, financial aspects, time spent with the doctor, accessibility, and convenience, as well as overall general satisfaction. | From enrollment to end of postoperative follow up at 6-months |
| Grip/Strength Assessment | Measured using a hand-held dynamometer in units of pounds/kilograms | From enrollment to end of postoperative follow up at 6-months |
| Range of Motion Assessment | Measured using a goniometer and recorded in degrees. | From enrollment to end of postoperative follow up at 6-months |
| Surgical Time | Total surgical time recorded in minutes. | From enrollment to end of postoperative follow up at 6-months |