NCT04629391

Brief Summary

There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

5.1 years

First QC Date

August 25, 2020

Last Update Submit

October 23, 2024

Conditions

Arthritis Shoulder

Keywords

shoulderprimary osteoarthritisRange of motionclinical outcomesradiographic outcomesanatomic prosthesisreverse prosthesisArthroplasty

Outcome Measures

Primary Outcomes (1)

  • Change in American Shoulder and Elbow Surgeons score (ASES)

    General clinical score (0-100, with 100 being the best score possible)

    Between baseline and 2 postoperative years

Secondary Outcomes (7)

  • Change in Subjective Shoulder Value (SSV)

    Between baseline and 2 postoperative years

  • Change in Range of motion in degrees

    Between baseline and 2 postoperative years

  • Complication rates

    2 postoperative years.

  • Change in pain on visual analogic scale (pVAS)

    Between baseline and 2 postoperative years

  • Change in Constant score

    Between baseline and 2 postoperative years

  • +2 more secondary outcomes

Study Arms (2)

Anatomic TSA

ACTIVE COMPARATOR

The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis

Device: Total shoulder arthroplasty

RTSA

EXPERIMENTAL

The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis

Device: Total shoulder arthroplasty

Interventions

Total shoulder arthroplastyDEVICE

A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.

Anatomic TSARTSA

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Primary glenohumeral arthritis,
  • Intact rotator cuff,

You may not qualify if:

  • Patients between 65 and 85 years old
  • Informed Consent as documented by signature (Appendix Informed Consent Form).
  • B2 glenoid with \> 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
  • B3 and C type glenoids,
  • Full thickness rotator cuff tear,
  • Acute or malunited proximal humeral fracture,
  • Chronic locked dislocation
  • Rheumatoid arthritis,
  • Revision surgery or surgical antecedents,
  • Tumors,
  • Axillary nerve damage,
  • Non-functioning deltoid muscle,
  • Glenoid vault deficiency precluding baseplate fixation,
  • Infection and neuropathic joints,
  • Known or suspected non-compliance, drug or alcohol abuse,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Tour Hospital

Meyrin, 1217, Switzerland

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Alexandre Lädermann, MD

    La Tour Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Lädermann, MD

CONTACT

+41 22 719 75 55alexandre.laedermann@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
While the patients and care providers will be aware of the type of prosthesis, the physicians who assessed the outcomes and analyzed the data will be blinded to this information.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2020

First Posted

November 16, 2020

Study Start

September 1, 2020

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)