A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

NCT04507880 | Unknown DMC FDA Device

• 1 other identifier: 71005
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.

Conditions

Shoulder Fractures

Keywords

Humeral Fractures, Proximal

Outcome Measures

Primary Outcomes (1)

• Change in Constant score (CS)

  The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.

  The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

Secondary Outcomes (6)

• Change in Oxford Shoulder Score (OSS)

  The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

• Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

  The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

• Change in EQ5D questionnaire

  The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

• Change in Numeric Ranking Scale

  The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

• Complications

  The outcome is registered 2 years after surgery

Study Arms (2)

RTSA group

EXPERIMENTAL

Participants with a complex proximal humerus fracture given a RTSA

Device: Reverse Total Shoulder Arthroplasty

Hemiarthroplasty group

ACTIVE COMPARATOR

Historical cohort of participants, operated with a hemiarthroplasty of the shoulder

Device: Hemiarthroplasty

Interventions

Reverse Total Shoulder Arthroplasty DEVICE

The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.

RTSA group

Hemiarthroplasty DEVICE

The shoulder hemiarthroplasty

Hemiarthroplasty group

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
• Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
• All patients, regardless of age, with an insufficient or irreparable rotator cuff

You may not qualify if:

• Brachial plexus palsy
• Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
• Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
• Patients without a Danish civil registration number

Sponsors & Collaborators

• Signe Rosner Rasmussen: lead
• Herlev and Gentofte Hospital: collaborator

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Bo S Olsen, Professor

  Herlev and Gentofte Hospital

  STUDY CHAIR

Central Study Contacts

Signe R Rasmussen, MD

CONTACT

+4526623427; signe.nanna.rosner.rasmussen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, orthopedic resident, principal investigator

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 11, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share