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Efficacy of a New Resurfacing Hip Prosthesis

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Articular Surface Replacement (ASR) hip prosthesis
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring "resurfacing hip" [MESH], "conventional position method", "surgery, computer-assisted" [MESH]

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laurentius Hospital
  • Maxima Medical Center, location Eindhoven
  • Medical Center Haaglanden, location Westeinde Hospital
  • Medical Center Haaglanden, location Antoniushove
  • Erasmus Medical Center
  • Oosterschelde Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

ASR prosthesis placed using CAS

ASR prosthesis placed by conventional method

Outcomes

Primary Outcome Measures

pre planned position of the femoral component preoperatively (stem-shaft-angle)
actual position of the femoral component postoperatively (stem-shaft-angle)

Secondary Outcome Measures

Harris Hip Score
Hip pain
Assessments of the position of femoral component (biomechanical parameters) at the X-rays
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)
Quality of life
Early complications
Later complications

Full Information

First Posted
October 24, 2006
Last Updated
February 28, 2013
Sponsor
Erasmus Medical Center
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00391937
Brief Title
Efficacy of a New Resurfacing Hip Prosthesis
Official Title
Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Johnson & Johnson

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
"resurfacing hip" [MESH], "conventional position method", "surgery, computer-assisted" [MESH]

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ASR prosthesis placed using CAS
Arm Title
2
Arm Type
Active Comparator
Arm Description
ASR prosthesis placed by conventional method
Intervention Type
Device
Intervention Name(s)
Articular Surface Replacement (ASR) hip prosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
pre planned position of the femoral component preoperatively (stem-shaft-angle)
Time Frame
within 8 weeks before surgery
Title
actual position of the femoral component postoperatively (stem-shaft-angle)
Time Frame
within one week after surgery
Secondary Outcome Measure Information:
Title
Harris Hip Score
Time Frame
preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Title
Hip pain
Time Frame
preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Title
Assessments of the position of femoral component (biomechanical parameters) at the X-rays
Time Frame
preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Title
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time Frame
preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Title
Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)
Time Frame
preoperatively and at 3 and 6 months postoperatively
Title
Quality of life
Time Frame
preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
Title
Early complications
Time Frame
within 3 months after surgery
Title
Later complications
Time Frame
longer than 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAN Verhaar, PhD MD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Laurentius Hospital
City
Roermond
State/Province
Limburg
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Maxima Medical Center, location Eindhoven
City
Eindhoven
State/Province
North Brabant
ZIP/Postal Code
5600 PD
Country
Netherlands
Facility Name
Medical Center Haaglanden, location Westeinde Hospital
City
Den Haag
State/Province
South Holland
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
Medical Center Haaglanden, location Antoniushove
City
Leidschendam
State/Province
South Holland
ZIP/Postal Code
2260 AK
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Oosterschelde Hospital
City
Goes
State/Province
Zeeland
ZIP/Postal Code
4462 RA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31651318
Citation
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.
Results Reference
derived

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Efficacy of a New Resurfacing Hip Prosthesis

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