Efficacy of a New Resurfacing Hip Prosthesis

Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study

The purpose of this study is to compare the articular surface replacement (ASR) prosthesis placed by the conventional positioning method and the ASR prosthesis placed by 'computer assisted surgery' (CAS) in variation between pre planned position of the femoral component and the actual position of the femoral component of the prosthesis. The hypothesis is that this variation is larger with the conventional positioning method than when CAS is used.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Device: Articular Surface Replacement (ASR) hip prosthesis

Detailed Description

For patients who suffer from end stage of osteoarthritis of the hip, a joint replacement could result in an obvious improvement of the quality of life. However, because of the life expectation and high level of activity of young and active patients, the conventional total hip replacement does not offer an optimal solution.

An alternative to a total hip replacement in young and active patients is the resurfacing hip prostheses. The articular surface replacement (ASR) hip prostheses can be placed by the conventional positioning method and by using 'computer assisted surgery' (CAS). The hypothesis is that the positioning of the femoral component by the conventional positioning method will show a larger variation between pre planned and actual position than when CAS is used.

This study will compare the results of those who had an ASR prosthesis placed by the conventional positioning method with those patients in whom the ASR prosthesis was placed using CAS.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Roermond, Limburg, Netherlands, 6043 CV
      • Laurentius Hospital
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5600 PD
      • Maxima Medical Center, location Eindhoven
  • South Holland
    • Den Haag, South Holland, Netherlands, 2501 CK
      • Medical Center Haaglanden, location Westeinde Hospital
    • Leidschendam, South Holland, Netherlands, 2260 AK
      • Medical Center Haaglanden, location Antoniushove
    • Rotterdam, South Holland, Netherlands, 3000 CA
      • Erasmus Medical Center
  • Zeeland
    • Goes, Zeeland, Netherlands, 4462 RA
      • Oosterschelde Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men aged ≤ 60 years, and women aged ≤ 55 years
• Presence of evident clinical and radiological osteoarthritis of the hip, indicated for a joint replacement surgery

Exclusion Criteria:

• Evident osteoporosis
• Active local or systemic infection
• Clinical manifestation of vascular deficiency of the lower extremity
• Pathological condition of the acetabulum
• Presence of evident clinical and radiological avascular necrosis of the femoral head, hip dysplasia, slipped capital femoral epiphysis, Legg-Calve- Perthes disease
• Rheumatoid arthritis
• Extreme varus position (neck-shaft angle < 110º)
• Presence of femoral cyst > 1 cm in diameter
• Previous hip surgery
• Presence of bilateral hip pathology, which may lead to joint replacement surgery within 1 year
• Presence of a THR at the contra lateral site less than 6 months post- operatively or patients with a THR at the contra lateral site with a poor function of the hip
• BMI> 30 kg/m2
• Renal deficiency (creatine > 115 μmol/l for men and > 90 μmol/l for women)
• Medically proven metal allergy
• Request of patient to correct an existing leg length discrepancy
• Head-neck ratio < 1
• Use of steroids, and/or immunosuppressive medication
• Alcoholism
• Patients from which it is not sure that they will be able to attend the follow-up measurements
• Insufficient command of the Dutch language, spoken and/of written

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; ASR prosthesis placed using CAS	Device: Articular Surface Replacement (ASR) hip prosthesis; a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0.
Active Comparator: 2; ASR prosthesis placed by conventional method	Device: Articular Surface Replacement (ASR) hip prosthesis; a DePuy ASR™ primary resurfacing femoral and acetabular component (DePuy International Ltd, Leeds, UK). The cement that will be used is one dose of DePuy SmartSet® GHV 40 gram, a high-viscosity cement with gentamycin (DePuy CMW, Blackpool, UK). Instrumentation includes standard ASR™ instruments and Ci™ Software for DePuy ASR™ System1.0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pre planned position of the femoral component preoperatively (stem-shaft-angle)	within 8 weeks before surgery
actual position of the femoral component postoperatively (stem-shaft-angle)	within one week after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Harris Hip Score	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Hip pain	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Assessments of the position of femoral component (biomechanical parameters) at the X-rays	preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)	preoperatively and at 3 and 6 months postoperatively
Quality of life	preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Early complications	within 3 months after surgery
Later complications	longer than 3 months after surgery

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Johnson & Johnson
• Investigators: Study Director: JAN Verhaar, PhD MD, Erasmus Medical Center

Publications and helpful links

General Publications

• Koper MC, Reijman M, van Es EM, Waarsing JH, Koot HWJ, Keizer SB, Jansen I, van Biezen FC, Verhaar JAN, Bos PK. No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial. BMC Musculoskelet Disord. 2019 Oct 25;20(1):473. doi: 10.1186/s12891-019-2883-7.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 24, 2006
• First Submitted That Met QC Criteria: October 24, 2006
• First Posted (Estimate): October 25, 2006

Study Record Updates

• Last Update Posted (Estimate): March 1, 2013
• Last Update Submitted That Met QC Criteria: February 28, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: "resurfacing hip" [MESH]; "conventional position method"; "surgery, computer-assisted" [MESH]
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 06-DP-001