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Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02983526
Enrollment
80
Registered
2016-12-06
Start date
2011-11-30
Completion date
2016-11-30
Last updated
2017-04-11

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

Conditions

Primary Osteoarthritis of Hip Nos, Secondary Osteoarthritis of Hip

Keywords

short stem

Brief summary

80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden. The patients were randomized to either CFP or Corail stem, both groups received Delta cup from Lima. Randomisation was done using envelopes. Patients could only participate with one hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.

Detailed description

The concept of femoral neck preserving hip replacement is intended for the young and active patients. By preserving proximal bone load, the transmission to the proximal femur is supposed to improve and future revision surgery would be facilitated. The hypothesis is that a more conservative resection of the femoral neck could lead to better clinical outcomes compared to a conventional stem. The clinical outcomes and the fixation of a short femoral stem were therefore compared with a stem of standard length. 83 patients were included in our randomized controlled trial where patients either received a Collum Femoris Preserving (CFP) stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are studied and the early migration is being measured using radiostereometric analysis. All of the patients have gone through 1 year follow-up. The 2 years results will be available at the end of 2017.

Interventions

DEVICETotal hip replacement (2 different designs)

Patients will randomly receive either CFP or Corail stem

Sponsors

Johan Karrholm
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* primary osteoarthritis of hip * secondary osteoarthritis due to hip dysplasia or Perthes under condition that the collum anatomy is well preserved and largely unaffected by the primary disease * avascular necrosis of femoral head * anatomy suitable for both designs according to preoperative planning

Exclusion criteria

* previous treatment with cortisone * generalized joint disease

Design outcomes

Primary

MeasureTime frameDescription
Oxford Hip ScorePreoperatively to 2 yearsThe Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.
Radiostereometric analysisPreoperatively to 2 yearsRadiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).

Secondary

MeasureTime frameDescription
Patient satisfaction (VAS), Pain (VAS)Preoperatively to 2 yearsPatient satisfaction and pain are reported on visual analogue scales.
Harris hip scorePreoperatively to 2 yearsOne of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026