NCT06025448

Brief Summary

This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
83mo left

Started Oct 2023

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

Study Progress27%
Oct 2023Mar 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
2 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

9.3 years

First QC Date

June 28, 2023

Last Update Submit

November 6, 2023

Conditions

Arthroplasty ComplicationsShoulder Osteoarthritis

Keywords

Reverse shoulder arthroplastyBIO-RSAMIO-RSABony lateralizationMetallic lateralizationOrthopedic Surgery

Outcome Measures

Primary Outcomes (1)

  • Migration of glenoid component from baseline until 24 months

    CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation. The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner) CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.

    At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.

Secondary Outcomes (7)

  • Change in WOOS Index

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in Constant-Murley Score

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in EuroQol-5

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in range of motion

    Before randomization, 3, 12 and 24 months postoperatively.

  • Change in Subjective Shoulder Value

    Before randomization, 3, 12 and 24 months postoperatively.

  • +2 more secondary outcomes

Study Arms (2)

BIO-RSA

ACTIVE COMPARATOR
Procedure: BIO-RSA

MIO-RSA

EXPERIMENTAL
Procedure: MIO-RSA

Interventions

BIO-RSAPROCEDURE

Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).

BIO-RSA
MIO-RSAPROCEDURE

Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).

MIO-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
  • massive glenoid medialization
  • 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 (1)

Lovisenberg Diaconal Hospital

Oslo, 0456, Norway

RECRUITING

Study Officials

  • Sigbjørn Dimmen, Prof.

    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

Christian Owesen, PhD

CONTACT

+4790515843cow@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

October 30, 2023

Primary Completion (Estimated)

March 1, 2033

Study Completion (Estimated)

March 1, 2033

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

NO(1)