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

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.

Study Overview

• Status: Completed
• Conditions: Primary Osteoarthritis of Hip Nos; Secondary Osteoarthritis of Hip
• Intervention / Treatment: Device: Total hip replacement (2 different designs)

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction (VAS), Pain (VAS)	Patient satisfaction and pain are reported on visual analogue scales.	Preoperatively to 2 years
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

Collaborators and Investigators

• Sponsor: Johan Karrholm
• Investigators: Principal Investigator: Johan Kärrholm, MD, PhD, Professor, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: short stem
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: CFP-SUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided