NCT06025331

Brief Summary

The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
88mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2023Aug 2033

First Submitted

Initial submission to the registry

June 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2033

Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

9.9 years

First QC Date

June 28, 2023

Last Update Submit

November 6, 2023

Conditions

Arthroplasty, Replacement, ShoulderShoulder Osteoarthritis

Keywords

Reverse Shoulder ArthroplastyBIO-RSAOrthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • Change in WOOS index from baseline to 24 months postoperatively.

    The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis. There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are often converted to a percentage of the maximum score.

    Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.

Secondary Outcomes (7)

  • Change in EuroQol-5 from baseline to 24 months postoperatively.

    Before randomization, 3, 12 and 24 months postoperatively.

  • CT scan

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in Constant-Murley Score from baseline to 24 months postoperatively.

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in range of motion from baseline to 24 months postoperatively.

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in Subjective Shoulder Value from baseline to 24 months postoperatively.

    Before randomization, 3, 12 and 24 months postoperatively.

  • +2 more secondary outcomes

Study Arms (2)

BIO-RSA

EXPERIMENTAL
Procedure: BIO-RSA

RSA

ACTIVE COMPARATOR
Procedure: RSA

Interventions

BIO-RSAPROCEDURE

Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed.

Also known as: Bony increased offset-reversed shoulder arthroplasty
BIO-RSA
RSAPROCEDURE

Conventional reversed shoulder arthroplasty(RSA) will be performed.

Also known as: Reverse shoulder arthroplasty
RSA

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
  • Able to read or write Norwegian

You may not qualify if:

  • Severe osteoporosis
  • Osteonecrosis of the humeral head
  • Dementia
  • Poor deltoid function
  • Revision surgery
  • ASA IV
  • Suspected chronic infection
  • Acute fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sykehuset Telemark HF

Skien, Telemark, 3710, Norway

NOT YET RECRUITING

Lovisenberg Diaconal Hospital

Oslo, 0456, Norway

RECRUITING

Study Officials

  • Sigbjørn Dimmen, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

  • Kjersti Kaul Jenssen, PhD

    Lovisenberg Diaconal Hospital

    PRINCIPAL INVESTIGATOR

  • Christian Owesen, PhD

    Lovisenberg Diaconal Hospital

    STUDY DIRECTOR

Central Study Contacts

Kjersti Kaul Jenssen, PhD

CONTACT

+4790200650KjerstiKaul.Jenssen@lds.no

Hanne Fuglø, MPTh

CONTACT

+4790524172hanne.fuglo@lds.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and health personnel examining the participants will be blinded. It will not be possible to blind the surgeons due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

September 6, 2023

Study Start

September 15, 2023

Primary Completion (Estimated)

August 1, 2033

Study Completion (Estimated)

August 1, 2033

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)