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

Sponsor

Regional Hospital Holstebro (Other)

Overall Status

Completed

CT.gov ID

NCT06019026

Collaborator

(none)

Enrollment

Arms

101.3

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip	Device: Tri-Lock Device: Summit	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized clinical trial

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Five-year Migration Pattern and Changes in Bone Mineral Density for the Tri-Lock and Summit Femoral Stems - Radiostereometric Analysis and Dual-energy X-ray Absorptiometry of 50 Patients.

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Aug 31, 2017

Actual Study Completion Date :

Jun 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tri-Lock Total hiparthroplasty performed through posterolateral access using the uncemented Tri-Lock short stem.	Device: Tri-Lock Implant Stem
Active Comparator: Summit Total hiparthroplasty performed through posterolateral access using the uncemented Summit standard stem.	Device: Summit Implant Stem

Arm

Intervention/Treatment

Experimental: Tri-Lock

Total hiparthroplasty performed through posterolateral access using the uncemented Tri-Lock short stem.

Device: Tri-Lock

Implant Stem

Active Comparator: Summit

Total hiparthroplasty performed through posterolateral access using the uncemented Summit standard stem.

Device: Summit

Implant Stem

Outcome Measures

Primary Outcome Measures

Migration (3D rotation and translation) Measured with radiostereometric analysis [5 years]
Subsidence (distal translation mm) and retroversion (negative vertical rotation deg.)
BMD measured with dual x-ray absorpmetry [5 years]
By Gruen zones, calculated as changes from baseline recording.

Secondary Outcome Measures

EQ5D [5 years]
Patient reported outcome. Generic - calculated as normalized time trade offf score up to 1 (best)
Oxford hip score [5 years]
Patient reported outcome. hip-score - from 0 to 48 (best)
Pain measured with VAS [5 years]
active and passive measures from 0 (worst) to 10 (best)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with primary hip osteoarthritis
Patients with adequate bone stock for insertion of uncemented components(no osteoporo-sis as assessed by pre-operative DXA scans)
Informed, written consent

Exclusion Criteria:

Patients with neuromuscular or vascular diseases in the affected leg
Patients intraoperatively found unfit to uncemented components
Patients who can not refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) in post-operative recovery
Patients with pre-operative fracture sequelae
Women who are, or have a wish for pregnancy during the study period.
Hip dysplasia or sequelae to Calves Perthes.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Regional Hospital Holstebro

Investigators

Principal Investigator: Torben Bæk Hansen, MD, PhD, Gødstrup Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Torben B. Hansen, Professor, MD PhD, Regional Hospital Holstebro

ClinicalTrials.gov Identifier:

NCT06019026

Other Study ID Numbers:

Tri-Lock vs. Summit

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Torben B. Hansen, Professor, MD PhD, Regional Hospital Holstebro

Radiostereometric analysis

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Aug 31, 2023