MedTrace Logo

Five-year Migration Pattern and Bone Mineral Density for the Tri-Lock and Summit Femoral Stems.

NCT06019026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-09-28

No results posted yet for this study

Summary

The incidence of primary hip joint prosthesis is 180 per. 100,000 inhabitants. In male patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over 15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and 78 % over 15 years.

As revision surgery is associated with higher complication risk for the patient and poorer out-come and implant survival it is necessary to examine possible methods that may increase long-term survival of the primary hip prosthesis or facilitate better outcomes after revision of hip joint prostheses for younger patients.

In younger patients the prosthesis often is inserted without the use of cement. When not using cement, it is crucial for the final result, that there is a direct bone ingrowth of the prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic surface.

This study investigates a new bone sparing implant with a new surface compared to a conventional implant.

Conditions

  • THA

Interventions

DEVICE

Tri-Lock

Implant Stem

DEVICE

Summit

Implant Stem

Sponsors & Collaborators

  • Regional Hospital Holstebro

    lead OTHER

Principal Investigators

  • Torben Bæk Hansen, MD, PhD · Gødstrup Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-08-31
Completion
2023-06-10

More Related Trials

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 NCT06019026 on ClinicalTrials.gov