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Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty

Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02247791
Acronym
CHANCE
Enrollment
140
Registered
2014-09-25
Start date
2009-09-30
Completion date
2024-09-30
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Brief summary

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

The study will randomize patients between an uncemented and cemented stem

Interventions

PROCEDUREUncemented femoral stem

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

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

Sponsors

Zimmer Biomet
CollaboratorINDUSTRY
Danderyd Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hip related complication rate2 yearsAll hip-related complications
Health-related Quality of Life2 yearsHealth related quality of life

Secondary

MeasureTime frameDescription
Duration of surgery2 years
Intraoperative bleeding2 years
Hip function2 yearsMeasured with Harris hip score

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026