Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral

NCT ID: NCT00318396

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction.

Hypothesis: Compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (RSA)\], less peri-prosthetic bone mineral density (BMD) loss \[evaluated by dual energy x-ray absorptiometry (DEXA)\], and a higher Harris hip score after two years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coxarthrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Compaction

The bone is pressed very hard together before implantation of femoral component.

Group Type EXPERIMENTAL

Bone preparation technique: compaction

Intervention Type PROCEDURE

The bone is pressed very hard together before implantation of femoral component.

Conventional technique

The bone is broached before implantation of femoral component.

Group Type ACTIVE_COMPARATOR

Bone preparation technique: conventional technique

Intervention Type PROCEDURE

Bone is broached before implantation of femoral component.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bone preparation technique: compaction

The bone is pressed very hard together before implantation of femoral component.

Intervention Type PROCEDURE

Bone preparation technique: conventional technique

Bone is broached before implantation of femoral component.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No other names. No other names.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with primary arthritis in the hip
* Patients with sufficient bone density to allow uncemented implantation of a femoral component
* Informed patient consent in writing

Exclusion Criteria

* Patients with neuromuscular or vascular disease in the affected leg
* Patients found upon operation to be unsuited for uncemented acetabulum component
* Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
* Patients with fracture sequelae
* Female patients of childbearing capacity
* Hip joint dysplasia
* Sequelae to previous hip joint disorder in childhood
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Soeren Kold, MD

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division

Kjeld Soeballe, MD, Prof.

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ON-04-002a-SKO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.