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

Primary Osteoarthritis of Hip Nos Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983526
• Other study ID #: CFP-SUH
• Status: Completed
• Phase: N/A
• First received: December 2, 2016
• Last updated: April 7, 2017
• Start date: November 2011
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Primary Osteoarthritis of Hip Nos
• Secondary Osteoarthritis of Hip

Intervention

Device:
• Total hip replacement (2 different designs)
Patients will randomly receive either CFP or Corail stem

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johan Karrholm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Hip Score	The 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.	Preoperatively to 2 years
Primary	Radiostereometric analysis	Radiostereometric 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).	Preoperatively to 2 years
Secondary	Patient satisfaction (VAS), Pain (VAS)	Patient satisfaction and pain are reported on visual analogue scales.	Preoperatively to 2 years
Secondary	Harris hip score	One of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.	Preoperatively to 2 years