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The overall objective of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in total knee replacement patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dHACM | Experimental | Total knee arthroplasty, per the usual practice of the physician with application of dHACM between the underlying fascia and the overlying skin layers to reduce scar formation |
|
| Control | Other | Total knee arthroplasty, per the usual practice of the physician without application of dHACM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Procedure | Total knee arthroplasty, per the usual practice of the physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increased range of motion between both groups as measured by goniometer | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of need for manual manipulation of affected knee | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increased Quality of Life as assessed by WOMAC and SF-36 | Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Short Form 36 (SF-36) are measures of patient health status and quality of life. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Jove, MD | Georgia Knee and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Knee and Sports Medicine | Decatur | Georgia | 30033 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Application of dHACM | Other | Application of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation |
|
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |