20000 Participants Needed

Shoulder Arthroplasty for Shoulder Osteoarthritis

Recruiting at 39 trial locations
RC
SA
Overseen BySandrine Angibaud
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Exactech
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the long-term effectiveness and safety of shoulder replacements (arthroplasty). Researchers will monitor individuals who have undergone or require shoulder replacement surgery for at least 10 years to collect this information. It suits those who need or have received a shoulder replacement and can attend follow-up visits. The trial seeks to determine if the surgery offers lasting benefits and identify any potential issues over time. As an unphased trial, participants contribute to valuable research that may enhance future shoulder replacement outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that shoulder arthroplasty is safe?

Research has shown that shoulder arthroplasty, a type of shoulder replacement surgery, is generally safe for patients. In one study, 90.7% of implants remained in good condition after several years, indicating that most implants performed well over time. Another study found that reverse shoulder arthroplasty, a specific type of shoulder replacement, reduced pain and improved function for patients with certain shoulder issues.

Total shoulder arthroplasty is also considered safe and effective, particularly for older adults. Patients often regain a good range of motion after surgery. Many shoulder replacements last more than ten years, providing long-lasting pain relief and improved shoulder function.

These findings suggest that shoulder arthroplasty is generally well-tolerated. Although serious issues, such as needing additional surgery within a year, can occur, they are uncommon. Overall, the procedure is regarded as a reliable way to improve shoulder problems over the long term.12345

Why are researchers enthusiastic about this study treatment?

Shoulder arthroplasty is unique because it replaces the damaged shoulder joint with artificial components, offering relief from severe arthritis or injury when other treatments like physical therapy or medications haven't worked. Unlike traditional methods, which might involve open surgery, advancements in surgical techniques and implant designs allow for less invasive procedures and potentially quicker recovery times. Researchers are excited about this approach because it can significantly improve mobility and quality of life for patients, providing a durable solution that mimics the natural shoulder's function.

What evidence suggests that shoulder arthroplasty is effective for long-term outcomes?

Research has shown that shoulder replacement surgery effectively treats shoulder issues. Studies have found that about 90% of shoulder replacements last over 10 years, providing patients with long-term pain relief and improved strength and movement. One study found that 94.6% of total shoulder replacements remained effective after a decade. Additionally, reverse total shoulder arthroplasty, a specific type of shoulder replacement, demonstrated that 88% of these surgeries did not require further intervention after 10 years. Overall, shoulder replacement surgery reliably maintains long-term shoulder health.56789

Who Is on the Research Team?

YK

Young Kwon, MD

Principal Investigator

Hospital for Joint Diseases - NYU Langone Health

RF

Richard Friedman, MD

Principal Investigator

Charleston Orthopaedic Associates

RJ

Richard Jones, MD

Principal Investigator

Southeastern Orthopedics and Spine

HR

Howard Routman, DO

Principal Investigator

Florida Atlantis Orthopaedics

RS

Ryan Simovitch, MD

Principal Investigator

Palm Beach Orthopaedic Institute

GA

Geoffrey Abrams, MD

Principal Investigator

Stanford Health Care

PH

Pierre Henri Flurin, MD

Principal Investigator

Centre de l'Arthrose

YM

Yann Marczuk, MD

Principal Investigator

Clinique Chenieux

HB

Harry Brownlow, MD

Principal Investigator

Circle Health Group

OD

Oliver Donaldson, MD

Principal Investigator

Yeovil District Hospital NHS Foundation

CR

Chris Roberts, MD

Principal Investigator

Ipswich Hospital

CP

Chris Peach, MD

Principal Investigator

University Hospital South Manchester

AD

Angelo Di Giunta, MD

Principal Investigator

Policlinico Morgagni

AR

Alfonso Romano, MD

Principal Investigator

Campolongo Hospital

SG

Sean Grey, MD

Principal Investigator

Orthopaedic and Spine Center of the Rockies

CM

Chad Manke, MD

Principal Investigator

Altantic Orthopaedics Specialists

RP

Rick Papandrea, MD

Principal Investigator

Orthopaedic Associates of Wisconsin

AC

Andrew Chambler, MD

Principal Investigator

The Sulis Hospital Bath

CN

Curt Noel, MD

Principal Investigator

Crystal Clinic Orthopaedic

TB

Tewfik Benkalfate, MD

Principal Investigator

Clinique Mutualiste la Sagesse

BS

Bradley Schoch, MD

Principal Investigator

Mayo Clinic

SP

Stephan Pill, MD

Principal Investigator

Steadman Hawkins Clinic of the Carolinas

ST

Scott Trenhaile, MD

Principal Investigator

OrthoIllinois

BB

Bryan Butler, MD

Principal Investigator

Orthopaedic Medical Group of Tampa Bay

BG

Ben Gooding, MD

Principal Investigator

Nottingham City Hospital

BC

Brad Carofino, MD

Principal Investigator

Altantic Orthopaedics Specialist

BS

Ben Sears, MD

Principal Investigator

Western Orthopaedics

KF

Kenneth Faber, MD

Principal Investigator

St Joseph's Health Care

JI

Jaicharan Iyengar, MD

Principal Investigator

Alpine Orthopaedic Medical Group

OA

Oke Anakwenze, MD

Principal Investigator

Duke Department of Orthopedic Surgery

TO

Thomas Obermeyer, MD

Principal Investigator

Barrington Orthopedic

AA

Alison Armstrong, MD

Principal Investigator

Leicester General Hospital

GM

George Malal, MD

Principal Investigator

Bedford Hospital

PM

Peter McCann, MD

Principal Investigator

Lenox Health Greenwich Village

SM

Stephanie Muh, MD

Principal Investigator

Henry Ford Health

JW

Jonathan Wright, MD

Principal Investigator

UF Health Orthopaedics and Sports Medicine Institute

SP

Stephen Parada, MD

Principal Investigator

Orthopedic and Sports Medicine

AY

Ari Youderian, MD

Principal Investigator

South County Orthopedic Specialists

IB

Ian Byram, MD

Principal Investigator

Bone and Joint Institute of Tennessee

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
Patient is at least 21 years of age
Patient is expected to survive at least 2 years beyond surgery
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants undergo shoulder arthroplasty and are evaluated for clinical and radiographic outcomes

10 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years
Annual visits

What Are the Treatments Tested in This Trial?

Interventions

  • Shoulder Arthroplasty

Find a Clinic Near You

Who Is Running the Clinical Trial?

Exactech

Lead Sponsor

Trials
17
Recruited
30,400+

Citations

Long-Term Outcomes Following Reverse Total Shoulder ...RTSA can provide satisfactory improvement of pain and function at long-term follow-up mean revision-free survivorship of 88% after 10 years.
How long does a shoulder replacement last? A systematic ...Our data show that approximately 90% of shoulder replacements last for longer than 10 years and patient-reported benefits are sustained.
an analysis of data from the National Joint RegistryAt a minimum of 2 years, 65.5% of HAs had returned to 1 or more sports compared with 97.3% of TSAs (P < .001). Reverse shoulder arthroplasties ...
Most shoulder replacements last longer than a decadeMost shoulder replacements give long-lasting improvements in pain, strength, range of movement, and ability to complete everyday tasks.
How long does a shoulder replacement last? A systematic ...The estimated 10-year survival for total shoulder replacement was 94·6% (95% CI 93·6–97·6) and humeral hemiarthroplasties was 90·4% (87·0–94·0). A single ...
Enhanced Outcomes and Safety of Reverse Shoulder ...In their study, the overall implant survival rate following reverse shoulder arthroplasty for all patients was 90.7% after a mean follow-up ...
Outcomes of reverse shoulder arthroplasty in patients with ...RSA can be considered a safe and reliable procedure for patients with os acromiale, offering improvements in both pain and function.
Total shoulder arthroplasty deemed safe, effective for ...Researchers noted “satisfactory” range of motion outcomes as postoperative active forward flexion ranged from 138 to 150 after TSA and 83 to 139 ...
Reverse total shoulder replacement versus anatomical ...Secondary outcomes included serious adverse events occurring within 90 days of surgery, reoperations within 12 months of surgery, prolonged ...
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