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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03145090
Other study ID # PUC-INTEVO (29BRC17.0027)
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 16, 2017
Est. completion date October 11, 2019

Study information

Verified date July 2018
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty


Description:

Knee osteoarthritis is a very common disease with significant functional consequences. Surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments.

Consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (PUC) is considered.

The scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment.

This study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date October 11, 2019
Est. primary completion date September 16, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition

Exclusion Criteria:

- Under 18 years old/ contraindications for bone scintigraphy/ refusal to participate

Study Design


Related Conditions & MeSH terms

  • Bone Scintigraphy and Knee Arthroplasty

Locations

Country Name City State
France CHRU de Brest Brest
France Clinique de La Baie Morlaix

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary modification in surgical strategy according to bone scintigraphy results pourcentage of therapeutic modification according to bone scintigraphy results 18 months