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Degenerative and Traumatic Pathology of the KneeNCT01191151

Web Based Orthopaedic Sports Medicine Registry

An observational study of Degenerative and Traumatic Pathology of the Knee and Degenerative and Traumatic Pathology of the Shoulder and Elbow, run by Arthrex, Inc. at 258 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 12 years and older
How many people
12,500 participants
Where
258 sitesin 5 countries
Study dates
Sep 2010to 30 Jul 2023
How long will I take part?
15 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Cohort will be selected from clinic patients scheduling surgery or nonoperative treatment

Who may be able to join

  • All patients electing to schedule routine and medically indicated orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment

Who cannot join

  • Non English or Spanish speaking
  • vulnerable populations, excluding minors

Trial locations and contacts

258 sites in 5 countries.

258 sites in 5 countries

United States220 sites

  • Capital Region Orthopaedics

    Albany, New York, 12206

  • New Mexico Orthopaedic Associates

    Albuquerque, New Mexico, 87106

  • Heartland Orthopedic Specialists

    Alexandria, Minnesota, 56308

  • Coordinated Health

    Allentown, Pennsylvania, 18104

  • Aubrey Smith Orthopedics

    Amarillo, Texas, 79106

  • Excelsior Orthopaedics, LLP

    Amherst, New York, 14226

  • Alaska Hand-Elbow-Shoulder Surgical Specialists

    Anchorage, Alaska, 99508

  • Anderson Clinic

    Arlington, Virginia, 22206

  • Asheville Orthopedic Associates

    Asheville, North Carolina, 28801

  • Southeastern Sports Medicine & Orthopedics

    Asheville, North Carolina, 28803

  • EmergeOrtho

    Asheville, North Carolina, 28804

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • Champions Orthopedics

    Augusta, Georgia, 30909

  • Children's Hospital Colorado (BioCartilage)

    Aurora, Colorado, 80045

  • Austin Sports Medicine

    Austin, Texas, 78705

  • Texas Institute for Hip & Knee Surgery

    Austin, Texas, 78751

  • Austin Shoulder Institute

    Austin, Texas, 78758

  • Ortho Stem Center

    Aventura, Florida, 33180

  • American Health Network

    Avon, Indiana, 46123

  • Adventist Health Bakersfield

    Bakersfield, California, 93301

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Suburban Orthopaedics

    Bartlett, Illinois, 60103

  • The Cleveland Shoulder Institute #2

    Beachwood, Ohio, 44122

  • Texas Orthopedic Specialists, PLLC

    Bedford, Texas, 76021

  • Agility Center

    Bentonville, Arkansas, 72712

  • Andrews Sports Medicine & Orthopedic Center

    Birmingham, Alabama, 35205

  • Advanced Orthopedics New England

    Bloomfield, Connecticut, 06002

  • Orthopedic Surgeons Inc

    Blue Springs, Missouri, 64014

  • Appalachian Regional

    Boone, North Carolina, 28607

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Institute for Sports Medicine

    Boulder, Colorado, 80301

  • Medical Center Bowling Green Clinic

    Bowling Green, Kentucky, 42101

  • Orthopaedic Surgery Associates

    Boynton Beach, Florida, 33435

  • Bridger Orthopaedic and Sports Medicine

    Bozeman, Montana, 59715

  • Coastal Orthopedics and Pain Management and Sports Medicine

    Bradenton, Florida, 34209

  • SUNY Downstate Health Sciences University

    Brooklyn, New York, 11203

  • North Tampa Orthopaedics & Sports Medicine

    Brooksville, Florida, 34613

  • Coastal Orthopedics & Sports Medicine

    Brunswick, Maine, 04011

  • Los Angeles Institute of Foot and Ankle Surgery

    Burbank, California, 91505

  • Lourdes Medical Assoc.

    Burlington, New Jersey, 08016

  • Blatz Orthopaedics and Sports Medicine

    Campbell, California, 95008

  • PRISM

    Campbell, California, 95008

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • OrthoCarolina

    Charlotte, North Carolina, 28207

  • Regeneration Orthopedics

    Chesterfield, Missouri, 63005

  • The Orthopedic Center of St. Louis

    Chesterfield, Missouri, 63017

  • Midwest Orthopedics at Rush

    Chicago, Illinois, 60612

  • Center for Athletic Medicine

    Chicago, Illinois, 60614

  • Adena Bone & Joint Center

    Chillicothe, Ohio, 45601

  • Beacon Orthopaedics and Sports Medicine LTD

    Cincinnati, Ohio, 45247

  • St. Peters Bone & Joint

    City of Saint Peters, Missouri, 63376

  • National Training Center, Sports Medicine Institute

    Clermont, Florida, 34711

  • University Hospitals

    Cleveland, Ohio, 44106

  • The Cleveland Shoulder Institute

    Cleveland, Ohio, 44124

  • Columbia Orthopedic Group

    Columbia, Missouri, 65201

  • Missouri Orthopaedic Institute

    Columbia, Missouri, 65212

  • Southern Indiana Orthopedics

    Columbus, Indiana, 47201

  • Columbus Orthopaedic Clinic

    Columbus, Mississippi, 39705

  • OhioHealth Orthopedic Surgeons

    Columbus, Ohio, 43215

  • UHZ Sports Medicine Institute

    Coral Gables, Florida, 33146

  • CNOS

    Dakota Dunes, South Dakota, 57049

  • OrthoONE at Rose Medical Center

    Denver, Colorado, 80220

  • Advanced Orthopedic and Sports Medicine Specialists

    Denver, Colorado, 80230

  • Humphrey Shoulder Clinic

    Eagle, Idaho, 83616

  • Ortho Michigan

    Flint, Michigan, 48507

  • McLeod Health

    Florence, South Carolina, 29506

  • Integrative Sports Medicine LLC

    Fort Collins, Colorado, 80525

  • Joint Implant Surgeons of Florida

    Fort Myers, Florida, 33907

  • Texas Health

    Fort Worth, Texas, 76104

  • Bone and Joint Institute of Tennessee

    Franklin, Tennessee, 37067

  • Sierra Pacific Orthopedics

    Fresno, California, 93720

  • Craig Ranch Orthopaedics

    Frisco, Texas, 75034

  • Fox Valley Orthopaedic Institute

    Geneva, Illinois, 60134

  • G2 Orthopedics and Sports Medicine

    Glen Allen, Virginia, 23059

  • North Jersey Orthopaedic Clinic

    Glen Rock, New Jersey, 07452

  • Panorama Orthopedic & Spine Center

    Golden, Colorado, 80401

  • River Valley Orthopedics

    Grand Rapids, Michigan, 49503

  • West Michigan Orthopedics

    Grand Rapids, Michigan, 49546

  • Prevea Health

    Green Bay, Wisconsin, 54304

  • ONS

    Greenwich, Connecticut, 06831

  • Steadman Hawkins Clinic

    Greenwood Village, Colorado, 80111

  • Andrews Orthopaedic & Sports Medicine Center

    Gulf Breeze, Florida, 32561

  • Fondren Orthopedic Group

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Mississippi Sports Medicine

    Jackson, Mississippi, 39202

  • Mercy Health System

    Janesville, Wisconsin, 53546

  • Ochsner Sports Medicine Institute

    Jefferson, Louisiana, 70121

  • MK Orthopaedics, Surgery and Rehabilitation

    Joliet, Illinois, 60435

  • Advanced Shoulder Orthopaedics

    Jupiter, Florida, 33458

  • KUMC

    Kansas City, Kansas, 66160

  • Louisiana State University

    Kenner, Louisiana, 70065

  • Orthopedics International

    Kirkland, Washington, 98034

  • Armstrong County Memorial Hospital

    Kittanning, Pennsylvania, 16201

  • Tennessee Orthopaedic Clinics

    Knoxville, Tennessee, 37923

  • OrthoKnox

    Knoxville, Tennessee, 37934

  • Lafayette General Orthopaedic Center

    Lafayette, Louisiana, 70506

  • Louisiana Orthopaedic Specialists

    Lafayette, Louisiana, 70508

  • National Sports Medicine Institute

    Lansdowne Town Center, Virginia, 20176

  • Mid-Michigan Orthopaedic Institution

    Lansing, Michigan, 48823

  • Laredo Sports Medicine Clinic

    Laredo, Texas, 78045

  • Las Cruces Orthopaedic Associates

    Las Cruces, New Mexico, 88005

  • Desert Orthopaedic Center

    Las Vegas, Nevada, 89121

  • Total Sports Medicine

    Las Vegas, Nevada, 89144

  • Mercer-Bucks Orthopaedics

    Lawrence, New Jersey, 08648

  • Orthopaedic and Sports Medicine Consultants

    Leawood, Kansas, 66211

  • Advanced Orthopedic & Sports Medicine dba Sano

    Lee's Summit, Missouri, 64063

  • BlueGrass Orthopedics

    Lexington, Kentucky, 40509

  • Illinois Bone and Joint Institute

    Libertyville, Illinois, 60048

  • Greater Long Beach Orthopaedics

    Los Alamitos, California, 90720

  • USC Department of Orthopedic Surgery

    Los Angeles, California, 90033

  • Kerlan Jobe Orthopaedic Clinic

    Los Angeles, California, 90045

  • Center for Orthopedic Surgery

    Lubbock, Texas, 79416

  • TTUHSC Department of Orthopedics

    Lubbock, Texas, 79430

  • Mammoth Hospital

    Mammoth Lakes, California, 93546

  • Summit Orthopedics

    Maplewood, Minnesota, 55109

  • Premier Hip Arthroscopy

    Marina del Rey, California, 90292

  • Southern Oregon Orthopedics

    Medford, Oregon, 97504

  • First Choice Medical Group

    Melbourne, Florida, 32901

  • Rush Foundation Hospital

    Meridian, Mississippi, 39301

  • OrthoMiami

    Miami, Florida, 33173

  • West Texas Orthopedics

    Midland, Texas, 79701

  • Orthomed Center

    Modesto, California, 95355

  • Southern Orthopaedic Surgeons

    Montgomery, Alabama, 36117

  • Central Indiana Orthopedics

    Muncie, Indiana, 47304

  • Collier Sports Medicine

    Naples, Florida, 34110

  • Ortho.Boston

    Needham Heights, Massachusetts, 02494

  • Henry Community Orthopaedics and Sports Medicine

    New Castle, Indiana, 47362

  • Mount Sinai Medical Center

    New York, New York, 10021

  • NY Orthopedics

    New York, New York, 10075

  • First State Orthopaedics

    Newark, Delaware, 19713

  • Orthopedic Care Physician Network

    North Easton, Massachusetts, 02356

  • Marin Orthopedic and Sports Medicine

    Novato, California, 94945

  • Motor City Orthopedics and Sports Medicine Institute

    Novi, Michigan, 48374

  • Advanced Orthopedic and Spine Care

    Oak Lawn, Illinois, 60453

  • Seaview Orthopedics

    Ocean City, New Jersey, 07712

  • Oklahoma Sports Science and Orthopedics

    Oklahoma City, Oklahoma, 73114

  • Maryland Sports Medicine Center

    Olney, Maryland, 20832

  • Potomac Valley Orthopaedic Associates, Chartered

    Olney, Maryland, 20832

  • Oneida Health

    Oneida, New York, 13421

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Oregon Orthopedic & Sports Medicine Clinic, LLP

    Oregon City, Oregon, 97045

  • Midwest Orthopaedic Consultants

    Orland Park, Illinois, 60467

  • Skyline Orthopedics

    Orland Park, Illinois, 60467

  • Congress Orthopaedic Associates

    Pasadena, California, 91105

  • Temple Orthopaedics and Sports Medicine

    Philadelphia, Pennsylvania, 19140

  • Steward Orthopedics and Sports Medicine

    Phoenix, Arizona, 85016

  • The Orthopedic Clinic Association (Biocartilage)

    Phoenix, Arizona, 85016

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • The Orthopedic Clinic Association

    Phoenix, Arizona, 85106

  • Burke and Bradley Orthopedics

    Pittsburgh, Pennsylvania, 15215

  • UPMC-St. Margarets Hospital

    Pittsburgh, Pennsylvania, 15215

  • Children's Health

    Plano, Texas, 75024

  • Frank McCormick MD

    Pompano Beach, Florida, 33062

  • OA center for Orthopedics

    Portland, Maine, 04102

  • Advanced Orthopedics

    Richmond, Virginia, 23294

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Ascension Medical Group

    Rochester Hills, Michigan, 48307

  • Michigan Center for Regenerative Medicine

    Rochester Hills, Michigan, 48307

  • Harbin Clinic

    Rome, Georgia, 30165

  • The Orthopedic Specialty Center of Northern California

    Roseville, California, 95678

  • Sacramento Orthopedic Center

    Sacramento, California, 95816

  • Orthopaedic Associates of St. Augustine

    Saint Augustine, Florida, 32086

  • Peninsula Orthopaedic Assoc.

    Salisbury, Maryland, 21804

  • Heiden Orthopedics

    Salt Lake City, Utah, 84121

  • OSSMSA

    San Antonio, Texas, 78209

  • The San Antonio Orthopaedics Group

    San Antonio, Texas, 78216

  • The San Antonio Orthopaedic Group

    San Antonio, Texas, 78258

  • John G. Lane MD Inc.

    San Diego, California, 92111

  • Synergy Specialists Medical Group

    San Diego, California, 92121

  • Advanced Orthopaedics and Sports Medicine Inc.

    San Francisco, California, 94108

  • California Pacific Medical Center

    San Francisco, California, 94114

  • Anderson Knee and Shoulder Center

    San Francisco, California, 94115

  • SBSPMA

    San Francisco, California, 94117

  • Alta Orthopaedics

    Santa Barbara, California, 93101

  • Orthopedic Surgical Practice

    Santa Barbara, California, 93111

  • Children's Hospital Los Angeles

    Santa Monica, California, 90027

  • Santa Monica Orthopedics and Sports Medicine Group

    Santa Monica, California, 90404

  • Florida Orthopedic Foot & Ankle Center

    Sarasota, Florida, 34239

  • Arizona Bone and Joint Specialists

    Scottsdale, Arizona, 85254

  • The Sports Medicine Clinic

    Seattle, Washington, 98133

  • Skyview Orthopedic Associates

    Sparta, New Jersey, 07871

  • Sterling Ridge Orthopaedics & Sports Medicine

    Spring, Texas, 77379

  • Bluetail Medical Group

    St Louis, Missouri, 63141

  • Motion Orthropaedics

    St Louis, Missouri, 63141

  • Starkville Orthopedic Clinic

    Starkville, Mississippi, 39759

  • Manhattan Orthopedic Care

    Staten Island, New York, 10306

  • Regional Orthopedics

    Staten Island, New York, 10314

  • BioLOGIC Regenerative Medicine

    Steamboat Springs, Colorado, 80487

  • Orthopaedics of Steamboat Springs

    Steamboat Springs, Colorado, 80487

  • Atlanta Orthopaedic Institute

    Stockbridge, Georgia, 30281

  • Tallahassee Orthopedic Clinic (Mejia)

    Tallahassee, Florida, 32308

  • Taos Orthopaedic Institute

    Taos, New Mexico, 87571

  • Sports Medicine Oregon

    Tigard, Oregon, 97224

  • Toledo Orthopaedic Surgeons

    Toledo, Ohio, 43615

  • Azalea Orthopedics

    Tyler, Texas, 75703

  • Valdosta Orthopedic Associates

    Valdosta, Georgia, 31602

  • Atlantic Orthopaedic Specialists

    Virginia Beach, Virginia, 23452

  • Virginia Institute for Sports Medicine

    Virginia Beach, Virginia, 23454

  • Advent Healthcare

    Waco, Texas, 76708

  • Waco Orthopedic & Sports Medicine Clinic

    Waco, Texas, 76710

  • So County Orthopaedics

    Wakefield, Rhode Island, 02879

  • Walnut Creek Orthopedics & Sports Medicine

    Walnut Creek, California, 94596

  • Joint Preservation Institute

    Walnut Creek, California, 94598

  • Muir Orthopaedic Specialists

    Walnut Creek, California, 94598

  • Boston Sports & Shoulder Center

    Waltham, Massachusetts, 02451

  • Washington Orthopaedics & Sports Medicine

    Washington D.C., District of Columbia, 20006

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Medstar/Georgetown University

    Washington D.C., District of Columbia, 70002

  • Mansfield Orthopaedics

    Waterbury, Vermont, 05676

  • Weirton Medical Center

    Weirton, West Virginia, 26062

  • Samimi Orthopedic Group

    West Covina, California, 91790

  • Center of Orthopedic & Rehabilitation Excellence

    West Jordan, Utah, 84088

  • Mid-America Orthopedics

    Wichita, Kansas, 67206

  • Advanced Orthopaedic Associates

    Wichita, Kansas, 67226

  • Morgan Kalman Clinic

    Wilmington, Delaware, 19810

  • Orthopedic Foot and Ankle Center

    Worthington, Ohio, 43085

Other trials in United States

South Africa19 sites

  • Alberlito Hospital

    Ballitoville

  • NMK Orthopaedics

    Berea

  • Sports Science Institute of South Africa

    Cape Town

  • Gateway Private Hospital

    Durban

  • Hillcrest Private Hospital

    Durban

  • Inkosi Albert Luthuli Hospital

    Durban

  • Life Entabeni Hospital

    Durban

  • Mediclinic Howick

    Howick

  • Walk A Mile Centre For Advanced Orthopaedics

    Lyttelton

  • Greenacres Hospital

    Newton Park

  • Maritzburg Orthopaedic Centre

    Northdale

  • Maritzburg Orthopaedic Centre

    Pietermaritzburg

  • Drs Beekarun Moodley Rajah And Partners

    Pinetown

  • Cape Shoulder Institute

    Plattekloof

  • Netcare Moot Hospital

    Rietfontein

  • Centre for Sports Medicine and Orthopaedics

    Rosebank, 2196

  • Center for Sports Medicine & Orthopaedics

    Rosebank

  • Umhlanga Medical Centre

    Umhlanga

  • Westville Hospital

    Westville

Other trials in South Africa

United Kingdom14 sites

  • Martyn Snow

    Birmingham, West Midlands, B31 2 AP

  • BMI Clementine Churchill Hospital

    Middlesex

  • Surrey Orthopaedic Clinic

    Ottershaw

  • NDORMS

    Oxford

  • Poole Hospital

    Poole

  • Circle Hospital

    Reading

  • Southampton University Hospital

    Southampton

  • Mackay Orthopaedic Associates

    Stirling, FK79JQ

  • MacKay Orthopaedic Associates

    Stirling

  • University Hospital of North Tees

    Stockton-on-Tees

  • Walsall Manor Hospital

    Walsall

  • Wrightington Hospital

    Wigan

  • The Windsor Knee Clinic

    Windsor

  • Windsor Knee Clinic

    Windsor

Other trials in United Kingdom

Canada4 sites

  • Durham Sports Specialists

    Ajax, Ontario, L1S 2J5

  • Fortius Sport & Health

    Burnaby, British Columbia, V5B 0A7

  • Pinnacle Health Sciences

    Richmond Hill, Ontario, L4C 1V7

  • Jason Smith Medical Corporation

    Scarborough Village, Ontario, M1E 5E9

Other trials in Canada

Puerto Rico1 site

  • Caribbean Shoulder and Elbow Institute

    San Juan, 00907

Other trials in Puerto Rico

About this study

Official title: Orthopaedic Sports Medicine, Arthroscopy, and Related Surgery Registry Using the Web-based OrthoIllustrated Surgical Outcomes System

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.

Keywords
Orthopedic surgery, sports medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01191151
Study groupRoleWhat they receive
Orthopedic injury, osteoarthritisAll eligible patients receiving orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completion30 Jul 2023
  4. Study completion30 Jul 2023

Why it stopped: Sponsor made buisness decision to close SOS Software, and terminate collecting data

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12,500 participants (actual)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT01191151
Sponsor's protocol ID
SOS #1
Status last verified
Aug 2024
First submitted
27 Aug 2010
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Gliklich RE, Dreyer NA, editors. Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK49444/

    PubMed 21204321

  • 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. No abstract available.

    PubMed 20360530

  • 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.

    PubMed 20439699

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative and Traumatic Pathology of the Knee and Degenerative and Traumatic Pathology of the Shoulder and Elbow, run by Arthrex, Inc. at 258 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 258 sites in United States, South Africa, United Kingdom, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor made buisness decision to close SOS Software, and terminate collecting data). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01191151, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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