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An RSA and DEXA Study on Migration of Proximal Interphalangeal (PIP) Joint Prostheses of the Hand

NCT00175188 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-10-13

No results posted yet for this study

Summary

The purpose of this study is to compare the early migration and the periprosthetic bone changes of cemented versus non-cemented interphalangeal implants using Roentgen stereophotogrammetric analysis and dual energy x-ray absorptiometry (DEXA). Furthermore, a thorough occupational therapist evaluation on the functional progress prior to and after surgery will be assessed.

Conditions

Interventions

DEVICE

Avanta (PIP joint implant with a titanium porous coating)

Implant is inserted at the time of surgery, after written consent

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Zimmer Biomet

    collaborator INDUSTRY

  • Avanta

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kjeld Søballe, MD, Prof. · Orthopaedic Center, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2010-08-31
Completion
2010-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00175188 on ClinicalTrials.gov