NCT04418050

Brief Summary

Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

June 5, 2020

Status Verified

March 1, 2020

Enrollment Period

Same day

First QC Date

April 17, 2020

Last Update Submit

June 4, 2020

Conditions

Prosthetic Arthroplasties

Keywords

paraplegiaShoulder prosthesisspinal cord injurywheelchair

Outcome Measures

Primary Outcomes (1)

  • Evolution of joint mobility

    Evolution of joint mobility

    1 day

Secondary Outcomes (1)

  • number of searches for early implant loosening

    1 day

Interventions

Shoulder arthroplastyPROCEDURE

Surgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients not walking or rarely walking, long-term users of a wheelchair

You may qualify if:

  • patients not walking or rarely walking, long-term users of a wheelchair before the intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis

You may not qualify if:

  • Patient walking without aid
  • Shoulder surgery other than arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

ParaplegiaSpinal Cord Injuries

Interventions

Arthroplasty, Replacement, Shoulder

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Léo Chiche, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

June 5, 2020

Study Start

February 1, 2010

Primary Completion

February 1, 2010

Study Completion

September 1, 2016

Last Updated

June 5, 2020

Record last verified: 2020-03

Locations

FR(1)