Study Stopped
problem due to new regulations for CE-marking of implants; lack of funding
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
In recent years, short femoral stems have been introduced. Short stems are designed based on traditional stems with good clinical results. The assumed benefit of short stems is that they are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic bone stock is better. Preservation of periprosthetic bone in the proximal femur is thought to secure long time anchoring of the implant, and reduce the risk of loosening. In addition, a good proximal bone stock makes later revision surgery less technically demanding. However, the short stem design could compromise the stability of the prosthesis, and there has been reported diverging results regarding correct positioning of short stems. This may be due to the lack of inherent aiming provided by the tip of the traditional long stems. We want to clinically evaluate the stability and bone remodelling pattern of a new short femoral stem based on a standard stem with excellent long time results. In addition we will compare the two different stems regarding positioning, when using a newly developed guiding broach for the short stem, and the standard broach for the long stem. Finally, patient reported clinical outcome scores will be evaluated with respect to implant and biomechanical reconstruction. The aim of this study is to evaluate whether this specific short femoral stem is stable, safe to use, and if it provides the expected beneficial effects on bone remodelling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2019
Typical duration for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedDecember 12, 2019
December 1, 2019
2 years
March 31, 2016
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in periprosthetic bone mineral density (BMD)
Postoperative change in BMD following bone remodelling measured by dual-energy x-ray absorptiometry (DXA)
2 years
Secondary Outcomes (5)
Migration of femoral stem
2 years
Biomechanical reconstruction of hip anatomy
2 years
Hip disability osteoarthritis outcome score (HOOS)
2 years
Harris hip score
2 years
Health-related quality of life (EQ-5D).
2 years
Study Arms (2)
Furlong Evolution femoral stem
EXPERIMENTALShort stem hip arthroplasty (SHA) using a Furlong Evolution femoral stem, and a Furlong H-A.C. Cortical Scree Fit (CSF) plus acetabular cup system.
Furlong H-A.C. femoral stem
ACTIVE COMPARATORTotal hip arthroplasty (THA) using a Furlong H-A.C. femoral stem, and a Furlong H-A.C. CSF plus acetabular cup system.
Interventions
Eligibility Criteria
You may qualify if:
- receiving primary total hip arthroplasty due to osteoarthritis, posttraumatic arthritis, avascular necrosis, or developmental hip dysplasia (Crowe grade 1)
You may not qualify if:
- osteoporosis
- pregnancy
- musculoskeletal problems compromising rehabilitation
- corticosteroid treatment
- dementia
- developmental dysplasia (Crowe grade II-IV)
- osteosynthesis in place
- revision surgery
- joint infection
- malignancy of the femur/pelvis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Olav Foss, md phd
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 19, 2016
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
December 12, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share