Degenerative and Traumatic Pathology of the Foot and Ankle Clinical Trial
Official title:
Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcomes System
| NCT number | NCT01191151 |
| Other study ID # | SOS #1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2010 |
| Est. completion date | June 2023 |
| Verified date | September 2021 |
| Source | Arthrex, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.
| Status | Recruiting |
| Enrollment | 12500 |
| Est. completion date | June 2023 |
| Est. primary completion date | June 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Inclusion Criteria: - All patients electing to schedule routine and medically indicated orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment Exclusion Criteria: - Non English or Spanish speaking - vulnerable populations, excluding minors |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Durham Sports Specialists | Ajax | Ontario |
| Canada | Fortius Sport & Health | Burnaby | British Columbia |
| Canada | Pinnacle Health Sciences | Richmond Hill | Ontario |
| Canada | Jason Smith Medical Corporation | Scarborough | Ontario |
| Puerto Rico | Caribbean Shoulder and Elbow Institute | San Juan | |
| South Africa | Alberlito Hospital | Ballitoville | |
| South Africa | NMK Orthopaedics | Berea | |
| South Africa | NMK Orthopaedics | Berea | |
| South Africa | Sports Science Institute of South Africa | Cape Town | |
| South Africa | Sports Science Institute of South Africa | Cape Town | |
| South Africa | Gateway Private Hospital | Durban | |
| South Africa | Gateway Private Hospital | Durban | |
| South Africa | Hillcrest Private Hospital | Durban | |
| South Africa | Inkosi Albert Luthuli Hospital | Durban | |
| South Africa | Life Entabeni Hospital | Durban | |
| South Africa | Life Entabeni Hospital | Durban | |
| South Africa | Mediclinic Howick | Howick | |
| South Africa | Walk A Mile Centre For Advanced Orthopaedics | Lyttelton | |
| South Africa | Greenacres Hospital | Newton Park | |
| South Africa | Greenacres Hospital | Newton Park | |
| South Africa | Maritzburg Orthopaedic Centre | Northdale | |
| South Africa | Maritzburg Orthopaedic Centre | Northdale | |
| South Africa | Maritzburg Orthopaedic Centre | Northdale | |
| South Africa | Maritzburg Orthopaedic Centre | Pietermaritzburg | |
| South Africa | Drs Beekarun Moodley Rajah And Partners | Pinetown | |
| South Africa | Cape Shoulder Institute | Plattekloof | |
| South Africa | Netcare Moot Hospital | Rietfontein | |
| South Africa | Center for Sports Medicine & Orthopaedics | Rosebank | |
| South Africa | Centre for Sports Medicine and Orthopaedics | Rosebank | |
| South Africa | Umhlanga Medical Centre | Umhlanga | |
| South Africa | Westville Hospital | Westville | |
| United Kingdom | Martyn Snow | Birmingham | West Midlands |
| United Kingdom | BMI Clementine Churchill Hospital | Middlesex | |
| United Kingdom | Surrey Orthopaedic Clinic | Ottershaw | |
| United Kingdom | NDORMS | Oxford | |
| United Kingdom | Poole Hospital | Poole | |
| United Kingdom | Circle Hospital | Reading | |
| United Kingdom | Southampton University Hospital | Southampton | |
| United Kingdom | Mackay Orthopaedic Associates | Stirling | |
| United Kingdom | MacKay Orthopaedic Associates | Stirling | |
| United Kingdom | University Hospital of North Tees | Stockton-on-Tees | |
| United Kingdom | Walsall Manor Hospital | Walsall | |
| United Kingdom | Walsall Manor Hospital | Walsall | |
| United Kingdom | Wrightington Hospital | Wigan | |
| United Kingdom | Wrightington Hospital | Wigan | |
| United Kingdom | The Windsor Knee Clinic | Windsor | |
| United Kingdom | Windsor Knee Clinic | Windsor | |
| United States | Capital Region Orthopaedics | Albany | New York |
| United States | New Mexico Orthopaedic Associates | Albuquerque | New Mexico |
| United States | Heartland Orthopedic Specialists | Alexandria | Minnesota |
| United States | Coordinated Health | Allentown | Pennsylvania |
| United States | Aubrey Smith Orthopedics | Amarillo | Texas |
| United States | Excelsior Orthopaedics, LLP | Amherst | New York |
| United States | Alaska Hand-Elbow-Shoulder Surgical Specialists | Anchorage | Alaska |
| United States | Anderson Clinic | Arlington | Virginia |
| United States | Asheville Orthopedic Associates | Asheville | North Carolina |
| United States | EmergeOrtho | Asheville | North Carolina |
| United States | Southeastern Sports Medicine & Orthopedics | Asheville | North Carolina |
| United States | King's Daughters Medical Center | Ashland | Kentucky |
| United States | Champions Orthopedics | Augusta | Georgia |
| United States | Children's Hospital Colorado (BioCartilage) | Aurora | Colorado |
| United States | Austin Shoulder Institute | Austin | Texas |
| United States | Austin Sports Medicine | Austin | Texas |
| United States | Texas Institute for Hip & Knee Surgery | Austin | Texas |
| United States | Ortho Stem Center | Aventura | Florida |
| United States | American Health Network | Avon | Indiana |
| United States | Adventist Health Bakersfield | Bakersfield | California |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Suburban Orthopaedics | Bartlett | Illinois |
| United States | The Cleveland Shoulder Institute #2 | Beachwood | Ohio |
| United States | Texas Orthopedic Specialists, PLLC | Bedford | Texas |
| United States | Agility Center | Bentonville | Arkansas |
| United States | Andrews Sports Medicine & Orthopedic Center | Birmingham | Alabama |
| United States | Advanced Orthopedics New England | Bloomfield | Connecticut |
| United States | Orthopedic Surgeons Inc | Blue Springs | Missouri |
| United States | Appalachian Regional | Boone | North Carolina |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Boulder Institute for Sports Medicine | Boulder | Colorado |
| United States | Medical Center Bowling Green Clinic | Bowling Green | Kentucky |
| United States | Orthopaedic Surgery Associates | Boynton Beach | Florida |
| United States | Bridger Orthopaedic and Sports Medicine | Bozeman | Montana |
| United States | Coastal Orthopedics and Pain Management and Sports Medicine | Bradenton | Florida |
| United States | SUNY Downstate Health Sciences University | Brooklyn | New York |
| United States | North Tampa Orthopaedics & Sports Medicine | Brooksville | Florida |
| United States | Coastal Orthopedics & Sports Medicine | Brunswick | Maine |
| United States | Los Angeles Institute of Foot and Ankle Surgery | Burbank | California |
| United States | Lourdes Medical Assoc. | Burlington | New Jersey |
| United States | Blatz Orthopaedics and Sports Medicine | Campbell | California |
| United States | PRISM | Campbell | California |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | OrthoCarolina | Charlotte | North Carolina |
| United States | Regeneration Orthopedics | Chesterfield | Missouri |
| United States | The Orthopedic Center of St. Louis | Chesterfield | Missouri |
| United States | Center for Athletic Medicine | Chicago | Illinois |
| United States | Midwest Orthopedics at Rush | Chicago | Illinois |
| United States | Adena Bone & Joint Center | Chillicothe | Ohio |
| United States | Beacon Orthopaedics and Sports Medicine LTD | Cincinnati | Ohio |
| United States | National Training Center, Sports Medicine Institute | Clermont | Florida |
| United States | The Cleveland Shoulder Institute | Cleveland | Ohio |
| United States | University Hospitals | Cleveland | Ohio |
| United States | Columbia Orthopedic Group | Columbia | Missouri |
| United States | Missouri Orthopaedic Institute | Columbia | Missouri |
| United States | Columbus Orthopaedic Clinic | Columbus | Mississippi |
| United States | OhioHealth Orthopedic Surgeons | Columbus | Ohio |
| United States | Southern Indiana Orthopedics | Columbus | Indiana |
| United States | UHZ Sports Medicine Institute | Coral Gables | Florida |
| United States | CNOS | Dakota Dunes | South Dakota |
| United States | Advanced Orthopedic and Sports Medicine Specialists | Denver | Colorado |
| United States | OrthoONE at Rose Medical Center | Denver | Colorado |
| United States | Humphrey Shoulder Clinic | Eagle | Idaho |
| United States | Ortho Michigan | Flint | Michigan |
| United States | McLeod Health | Florence | South Carolina |
| United States | Integrative Sports Medicine LLC | Fort Collins | Colorado |
| United States | Joint Implant Surgeons of Florida | Fort Myers | Florida |
| United States | Texas Health | Fort Worth | Texas |
| United States | Bone and Joint Institute of Tennessee | Franklin | Tennessee |
| United States | Sierra Pacific Orthopedics | Fresno | California |
| United States | Craig Ranch Orthopaedics | Frisco | Texas |
| United States | Fox Valley Orthopaedic Institute | Geneva | Illinois |
| United States | G2 Orthopedics and Sports Medicine | Glen Allen | Virginia |
| United States | North Jersey Orthopaedic Clinic | Glen Rock | New Jersey |
| United States | Panorama Orthopedic & Spine Center | Golden | Colorado |
| United States | River Valley Orthopedics | Grand Rapids | Michigan |
| United States | West Michigan Orthopedics | Grand Rapids | Michigan |
| United States | Prevea Health | Green Bay | Wisconsin |
| United States | ONS | Greenwich | Connecticut |
| United States | Steadman Hawkins Clinic | Greenwood Village | Colorado |
| United States | Andrews Orthopaedic & Sports Medicine Center | Gulf Breeze | Florida |
| United States | Fondren Orthopedic Group | Houston | Texas |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Mississippi Sports Medicine | Jackson | Mississippi |
| United States | Mercy Health System | Janesville | Wisconsin |
| United States | Ochsner Sports Medicine Institute | Jefferson | Louisiana |
| United States | MK Orthopaedics, Surgery and Rehabilitation | Joliet | Illinois |
| United States | Advanced Shoulder Orthopaedics | Jupiter | Florida |
| United States | KUMC | Kansas City | Kansas |
| United States | Louisiana State University | Kenner | Louisiana |
| United States | Orthopedics International | Kirkland | Washington |
| United States | Armstrong County Memorial Hospital | Kittanning | Pennsylvania |
| United States | OrthoKnox | Knoxville | Tennessee |
| United States | Tennessee Orthopaedic Clinics | Knoxville | Tennessee |
| United States | Lafayette General Orthopaedic Center | Lafayette | Louisiana |
| United States | Louisiana Orthopaedic Specialists | Lafayette | Louisiana |
| United States | National Sports Medicine Institute | Lansdowne Town Center | Virginia |
| United States | Mid-Michigan Orthopaedic Institution | Lansing | Michigan |
| United States | Laredo Sports Medicine Clinic | Laredo | Texas |
| United States | Las Cruces Orthopaedic Associates | Las Cruces | New Mexico |
| United States | Desert Orthopaedic Center | Las Vegas | Nevada |
| United States | Total Sports Medicine | Las Vegas | Nevada |
| United States | Mercer-Bucks Orthopaedics | Lawrence | New Jersey |
| United States | Orthopaedic and Sports Medicine Consultants | Leawood | Kansas |
| United States | Advanced Orthopedic & Sports Medicine dba Sano | Lee's Summit | Missouri |
| United States | BlueGrass Orthopedics | Lexington | Kentucky |
| United States | Illinois Bone and Joint Institute | Libertyville | Illinois |
| United States | Greater Long Beach Orthopaedics | Los Alamitos | California |
| United States | Kerlan Jobe Orthopaedic Clinic | Los Angeles | California |
| United States | USC Department of Orthopedic Surgery | Los Angeles | California |
| United States | Center for Orthopedic Surgery | Lubbock | Texas |
| United States | TTUHSC Department of Orthopedics | Lubbock | Texas |
| United States | Mammoth Hospital | Mammoth Lakes | California |
| United States | Summit Orthopedics | Maplewood | Minnesota |
| United States | Premier Hip Arthroscopy | Marina Del Rey | California |
| United States | Southern Oregon Orthopedics | Medford | Oregon |
| United States | First Choice Medical Group | Melbourne | Florida |
| United States | Rush Foundation Hospital | Meridian | Mississippi |
| United States | OrthoMiami | Miami | Florida |
| United States | West Texas Orthopedics | Midland | Texas |
| United States | Orthomed Center | Modesto | California |
| United States | Southern Orthopaedic Surgeons | Montgomery | Alabama |
| United States | Central Indiana Orthopedics | Muncie | Indiana |
| United States | Orthopedic Care Physician Network | N. Easton | Massachusetts |
| United States | Collier Sports Medicine | Naples | Florida |
| United States | Ortho.Boston | Needham Heights | Massachusetts |
| United States | Henry Community Orthopaedics and Sports Medicine | New Castle | Indiana |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | NY Orthopedics | New York | New York |
| United States | First State Orthopaedics | Newark | Delaware |
| United States | Marin Orthopedic and Sports Medicine | Novato | California |
| United States | Motor City Orthopedics and Sports Medicine Institute | Novi | Michigan |
| United States | Advanced Orthopedic and Spine Care | Oak Lawn | Illinois |
| United States | Seaview Orthopedics | Ocean City | New Jersey |
| United States | Oklahoma Sports Science and Orthopedics | Oklahoma City | Oklahoma |
| United States | Maryland Sports Medicine Center | Olney | Maryland |
| United States | Potomac Valley Orthopaedic Associates, Chartered | Olney | Maryland |
| United States | Oneida Health | Oneida | New York |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Oregon Orthopedic & Sports Medicine Clinic, LLP | Oregon City | Oregon |
| United States | Midwest Orthopaedic Consultants | Orland Park | Illinois |
| United States | Skyline Orthopedics | Orland Park | Illinois |
| United States | Congress Orthopaedic Associates | Pasadena | California |
| United States | Temple Orthopaedics and Sports Medicine | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Phoenix | Arizona |
| United States | Steward Orthopedics and Sports Medicine | Phoenix | Arizona |
| United States | The Orthopedic Clinic Association | Phoenix | Arizona |
| United States | The Orthopedic Clinic Association (Biocartilage) | Phoenix | Arizona |
| United States | Burke and Bradley Orthopedics | Pittsburgh | Pennsylvania |
| United States | UPMC-St. Margarets Hospital | Pittsburgh | Pennsylvania |
| United States | Children's Health | Plano | Texas |
| United States | Frank McCormick MD | Pompano Beach | Florida |
| United States | OA center for Orthopedics | Portland | Maine |
| United States | Advanced Orthopedics | Richmond | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Ascension Medical Group | Rochester Hills | Michigan |
| United States | Michigan Center for Regenerative Medicine | Rochester Hills | Michigan |
| United States | Harbin Clinic | Rome | Georgia |
| United States | The Orthopedic Specialty Center of Northern California | Roseville | California |
| United States | Sacramento Orthopedic Center | Sacramento | California |
| United States | Orthopaedic Associates of St. Augustine | Saint Augustine | Florida |
| United States | Bluetail Medical Group | Saint Louis | Missouri |
| United States | Motion Orthropaedics | Saint Louis | Missouri |
| United States | St. Peters Bone & Joint | Saint Peters | Missouri |
| United States | Peninsula Orthopaedic Assoc. | Salisbury | Maryland |
| United States | Heiden Orthopedics | Salt Lake City | Utah |
| United States | OSSMSA | San Antonio | Texas |
| United States | The San Antonio Orthopaedic Group | San Antonio | Texas |
| United States | The San Antonio Orthopaedics Group | San Antonio | Texas |
| United States | John G. Lane MD Inc. | San Diego | California |
| United States | Synergy Specialists Medical Group | San Diego | California |
| United States | Advanced Orthopaedics and Sports Medicine Inc. | San Francisco | California |
| United States | Anderson Knee and Shoulder Center | San Francisco | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | SBSPMA | San Francisco | California |
| United States | Alta Orthopaedics | Santa Barbara | California |
| United States | Orthopedic Surgical Practice | Santa Barbara | California |
| United States | Children's Hospital Los Angeles | Santa Monica | California |
| United States | Santa Monica Orthopedics and Sports Medicine Group | Santa Monica | California |
| United States | Florida Orthopedic Foot & Ankle Center | Sarasota | Florida |
| United States | Arizona Bone and Joint Specialists | Scottsdale | Arizona |
| United States | The Sports Medicine Clinic | Seattle | Washington |
| United States | Skyview Orthopedic Associates | Sparta | New Jersey |
| United States | Sterling Ridge Orthopaedics & Sports Medicine | Spring | Texas |
| United States | Starkville Orthopedic Clinic | Starkville | Mississippi |
| United States | Manhattan Orthopedic Care | Staten Island | New York |
| United States | Regional Orthopedics | Staten Island | New York |
| United States | BioLOGIC Regenerative Medicine | Steamboat Springs | Colorado |
| United States | Orthopaedics of Steamboat Springs | Steamboat Springs | Colorado |
| United States | Atlanta Orthopaedic Institute | Stockbridge | Georgia |
| United States | Tallahassee Orthopedic Clinic (Mejia) | Tallahassee | Florida |
| United States | Taos Orthopaedic Institute | Taos | New Mexico |
| United States | Sports Medicine Oregon | Tigard | Oregon |
| United States | Toledo Orthopaedic Surgeons | Toledo | Ohio |
| United States | Azalea Orthopedics | Tyler | Texas |
| United States | Valdosta Orthopedic Associates | Valdosta | Georgia |
| United States | Atlantic Orthopaedic Specialists | Virginia Beach | Virginia |
| United States | Virginia Institute for Sports Medicine | Virginia Beach | Virginia |
| United States | Advent Healthcare | Waco | Texas |
| United States | Waco Orthopedic & Sports Medicine Clinic | Waco | Texas |
| United States | So County Orthopaedics | Wakefield | Rhode Island |
| United States | Joint Preservation Institute | Walnut Creek | California |
| United States | Muir Orthopaedic Specialists | Walnut Creek | California |
| United States | Walnut Creek Orthopedics & Sports Medicine | Walnut Creek | California |
| United States | Boston Sports & Shoulder Center | Waltham | Massachusetts |
| United States | George Washington University | Washington | District of Columbia |
| United States | Medstar/Georgetown University | Washington | District of Columbia |
| United States | Washington Orthopaedics & Sports Medicine | Washington | District of Columbia |
| United States | Mansfield Orthopaedics | Waterbury | Vermont |
| United States | Weirton Medical Center | Weirton | West Virginia |
| United States | Samimi Orthopedic Group | West Covina | California |
| United States | Center of Orthopedic & Rehabilitation Excellence | West Jordan | Utah |
| United States | Advanced Orthopaedic Associates | Wichita | Kansas |
| United States | Mid-America Orthopedics | Wichita | Kansas |
| United States | Morgan Kalman Clinic | Wilmington | Delaware |
| United States | Orthopedic Foot and Ankle Center | Worthington | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Arthrex, Inc. |
United States, Canada, Puerto Rico, South Africa, United Kingdom,
Capozzi JD, Rhodes R. Examining the ethical implications of an orthopaedic joint registry. J Bone Joint Surg Am. 2010 May;92(5):1330-3. doi: 10.2106/JBJS.I.01410. — View Citation
Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User's Guide. AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality. April 2007.
Schemitsch EH, Bhandari M, Boden SD, Bourne RB, Bozic KJ, Jacobs JJ, Zdero R. The evidence-based approach in bringing new orthopaedic devices to market. J Bone Joint Surg Am. 2010 Apr;92(4):1030-7. doi: 10.2106/JBJS.H.01532. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in pain | 2 years |