Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty

NCT ID: NCT02247791

Last Updated: 2016-01-28

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2024-09-30

Brief Summary

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The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

Detailed Description

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The study will randomize patients between an uncemented and cemented stem

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cemented femoral stem

Patient undergoing total hip arthroplasty surgery

Group Type ACTIVE_COMPARATOR

Cemented femoral stem

Intervention Type PROCEDURE

All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Uncemented femoral stem

Patients undergoing total hip arthroplasty

Group Type ACTIVE_COMPARATOR

Uncemented femoral stem

Intervention Type PROCEDURE

All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Interventions

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Uncemented femoral stem

All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Intervention Type PROCEDURE

Cemented femoral stem

All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Intervention Type PROCEDURE

Other Intervention Names

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BiMetric uncemented femoral stem CPT cemented femoral stem

Eligibility Criteria

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Inclusion Criteria

* Acute Displaced femoral neck fracture
* Subject is aged between 65-79 years
* Independent walker with or without walking aides
* Subject is able and capable of providing consent to participate in the study

Exclusion Criteria

* Patients with Rheumatoid Arthritis
* Patients with an impaired cognitive dysfunction
* Patients with Pathological fractures
* Patients with substance abuse
* Patients with fracture older than 36-hours on arrival at the A\&E
* Patients suffering from cancer
* Patients determined by principal investigator to be unsuitable for inclusion
Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olof Skoldenberg

Director of research, Orthopaedic dept

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghazi Chammout, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden

Locations

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Danderyd Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Chammout G, Muren O, Boden H, Salemyr M, Skoldenberg O. Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial). BMC Musculoskelet Disord. 2016 Sep 20;17(1):398. doi: 10.1186/s12891-016-1253-y.

Reference Type DERIVED
PMID: 27646142 (View on PubMed)

Other Identifiers

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CHANCE

Identifier Type: -

Identifier Source: org_study_id

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