Exactech Shoulder Post Market Clinical Follow-up Study

NCT05603728 — Recruiting, 20000 participants, Exactech

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An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

RegistryNCT05603728
StatusRecruiting
Study typeObservational
Enrollment20000 (Estimated)
SponsorExactech (Industry)
ConditionsOsteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Fracture, Infections
Datesstart 2007-07-19, primary completion 2030-12-31 (estimated), completion 2031-12-31 (estimated), first posted 2022-11-03, last updated 2026-09-17
Locations40 sites in United States, Canada, France, Germany, Italy, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Osteo Arthritis Shoulders All trials for Osteonecrosis

-Summary

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

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+Outcome measures

Primary outcomes

  • Constant [Through study completion, an average of 1 per year]: Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain
  • ASES [Through study completion, an average of 1 per year]: American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition
  • Oxford Score (may be used as an optional form for surgeons in the United Kingdom) [Through study completion, an average of 1 per year]: Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability
  • TESS (may be used as specific forms related to the pre-operative condition/diagnosis) [Through study completion, an average of 1 per year]: Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome
  • MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) [Through study completion, an average of 1 per year]: Musculoskeletal Tumor Society (MSTS) - 30 points \[6 times (range 0-5)\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score

+Eligibility

Sex: All, ages: 21 Years to any

Inclusion Criteria:

* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
* Patient is skeletelly mature
* Patient is expected to survive at least 2 years beyond surgery
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Medial humeral bone loss resulting in compromised humeral stem fixation
* Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
* Neuromuscular disorders that do not allow control of the joint
* Significant injury to the brachial plexus
* Non-functional deltoid muscles
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient is contraindicated for the surgery
* Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)
* Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)
* Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)
* Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

+Locations (40)

FacilityCityCountryStatus
South County Orthopedic SpecialistsLaguna Woods, CaliforniaUnited StatesRecruiting
Stanford Health CareRedwood City, CaliforniaUnited StatesRecruiting
Alpine Orthopaedic Medical GroupStockton, CaliforniaUnited StatesRecruiting
Western OrthopaedicsDenver, ColoradoUnited StatesRecruiting
Orthopaedic and Spine Center of the RockiesFort Collins, ColoradoUnited StatesRecruiting
UF Health Orthopaedics and Sports Medicine InstituteGainesville, FloridaUnited StatesRecruiting
Mayo ClinicJacksonville, FloridaUnited StatesRecruiting
Florida Atlantis OrthopedicsPalm Beach Gardens, FloridaUnited StatesRecruiting
Orthopaedic Medical Group of Tampa BayTampa, FloridaUnited StatesRecruiting
HSS FloridaWest Palm Beach, FloridaUnited StatesRecruiting
Orthopedic and Sports MedicineAugusta, GeorgiaUnited StatesRecruiting
OrthoIllinoisRockford, IllinoisUnited StatesRecruiting
Barrington Orthpedic SpecialistsSchaumburg, IllinoisUnited StatesRecruiting
Henry Ford HealthDetroit, MichiganUnited StatesRecruiting
Hospital for Joint Diseases - NYU Langone HealthNew York, New YorkUnited StatesRecruiting
Lenox Health Greenwich VillageNew York, New YorkUnited StatesRecruiting
Southeastern Sports Medicine and OrthopedicsAsheville, North CarolinaUnited StatesRecruiting
Duke Department of Orthopedic SurgeryDurham, North CarolinaUnited StatesRecruiting
Crystal Clinic OrthopaedicAkron, OhioUnited StatesRecruiting
Charleston Orthopaedic AssociatesCharleston, South CarolinaUnited StatesRecruiting
Steadman Hawkins Clinic of the CarolinasGreenville, South CarolinaUnited StatesRecruiting
Bone and Joint Institute of TenesseeFranklin, TennesseeUnited StatesRecruiting
Atlantic Orthopaedics SpecialistsVirginia Beach, VirginiaUnited StatesRecruiting
Orthopaedic Associates of WisconsinPewaukee, WisconsinUnited StatesRecruiting
St Joseph's Health CareLondon, OntarioCanadaRecruiting
Clinique BelledoneGrenobleFranceRecruiting
Centre de l'arthroseMérignacFranceRecruiting
Clinique Mutualiste La SagesseRennesFranceRecruiting
Malteser Waldkrankenhaus ErlangenErlangenGermanyRecruiting
Orthopadische Praxisklinik Von VinckeMünsterGermanyRecruiting
Policlinico MorgagniCataniaItalyRecruiting
Campolongo HospitalEboliItalyRecruiting
Circle Health GroupReading, BerksUnited KingdomRecruiting
Yeovil District Hospital NHS Foundation TrustYeovil, SummersetUnited KingdomRecruiting
The Sulis Hospital BathBathUnited KingdomRecruiting
Bedford HospitalBedfordUnited KingdomRecruiting
Ipswich HospitalIpswichUnited KingdomRecruiting
Leicester General HospitalLeicesterUnited KingdomRecruiting
University Hospital South ManchesterManchesterUnited KingdomRecruiting
Nottingham University HospitalNottinghamUnited KingdomRecruiting

+Investigators