Efficacy of a New Resurfacing Hip Prosthesis

Condition(s) targeted: Osteoarthritis, Hip

Intervention: Articular Surface Replacement (ASR) hip prosthesis (Device)

Phase: Phase 3

Status: Recruiting

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
JAN Verhaar, PhD MD, Study Director, Affiliation: Erasmus Medical Center

Overall contact:
M Reijman, PhD, Phone: +31-10-4633642, Email: m.reijman@erasmusmc.nl

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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

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

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

M Reijman, PhD, Phone: +31-10-4633642, Email: m.reijman@erasmusmc.nl

Laurentius Hospital, Roermond, Limburg 6043 CV, Netherlands; Recruiting
G Dekkers, Phone: +31-475-382837, Email: g.dekkers@lrz.nl
g Dekkers, Principal Investigator

Maxima Medical Center, location Eindhoven, Eindhoven, North Brabant 5600 PD, Netherlands; Recruiting
HWJ Koot, Phone: +31-40-8888600, Email: h.koot@mmc.nl
WA d Boer, Phone: +31-40-8888600, Email: w.denboer@mmc.nl
HWJ Koot, Principal Investigator
WA d Boer, Sub-Investigator

Albert Schweitzer Hospital, Dordrecht, South Holland 3300AK, Netherlands; Recruiting
WRJ Pepels, Phone: +31-78-6542615, Email: w.r.j.pepels@asz.nl
AJ van Koeveringe, PhD, Phone: +31-78-6542664, Email: a.j.koeveringe@asz.nl
WRJ Pepels, Principal Investigator
AJ v Koeveringe, Sub-Investigator

Medical Center Rijnmond South, location Clara, Rotterdam, South Holland 3078HT, Netherlands; Recruiting
JLA Westerink, Phone: +31-10-2911736, Email: jla.westerink@hccnet.nl
JLA Westerink, Principal Investigator

Medical Center Haaglanden, location Westeinde Hospital, Den Haag, South Holland 2501 CK, Netherlands; Recruiting
SB Keizer, Phone: +31-70-3302056, Email: keiste@mchaaglanden.nl
SB Keizer, Principal Investigator

Medical Center Haaglanden, location Antoniushove, Leidschendam, South Holland 2260 AK, Netherlands; Recruiting
RE vd Flier, Phone: +31-70-3574147, Email: revanderflier@hotmail.com
RE vd Flier, Principal Investigator

Ruwaard van Putten Hospital, Spijkenisse, South Holland 3200 GA, Netherlands; Recruiting
AKH t Kate, Phone: +31-181-658458, Email: tenkate@rpz.nl
AKH t Kate, Principal Investigator

Erasmus Medical Center, Rotterdam, South Holland 3000 CA, Netherlands; Recruiting
M Reijman, PhD, Phone: +31-10-7033642, Email: m.reijman@erasmusmc.nl
MM Vissers, Msc, Phone: +31-10-7034070, Email: m.m.vissers@erasmusmc.nl
FC v Biezen, Principal Investigator
JAN Verhaar, Sub-Investigator
PK Bos, Sub-Investigator

Oosterschelde Hospital, Goes, Zeeland 4462 RA, Netherlands; Recruiting
I Jansen, Phone: +31-113-234225, Email: ijansen@soz.nl
FMM v Empel, Phone: +31-113-234225, Email: fvanempel@soz.nl
I Jansen, Principal Investigator
FMM v Empel, Sub-Investigator

Starting date: October 2006
Ending date: October 2011
Last updated: June 11, 2008