Clinical trial NCT00391937: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Hip
Keywords: "resurfacing hip" [MESH]
"conventional position method"
"surgery, computer-assisted" [MESH]
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2006-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pre planned position of the femoral component preoperatively (stem-shaft-angle)
timeFrame: within 8 weeks before surgery
measure: actual position of the femoral component postoperatively (stem-shaft-angle)
timeFrame: within one week after surgery
Secondary outcomes:
measure: Harris Hip Score
timeFrame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
measure: Hip pain
timeFrame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
measure: Assessments of the position of femoral component (biomechanical parameters) at the X-rays
timeFrame: preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively
measure: Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
timeFrame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
measure: Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)
timeFrame: preoperatively and at 3 and 6 months postoperatively
measure: Quality of life
timeFrame: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively
measure: Early complications
timeFrame: within 3 months after surgery
measure: Later complications
timeFrame: longer than 3 months after surgery
Other outcomes:
Locations:
city: Roermond
country: Netherlands
facility: Laurentius Hospital
state: Limburg
city: Eindhoven
country: Netherlands
facility: Maxima Medical Center, location Eindhoven
state: North Brabant
city: Den Haag
country: Netherlands
facility: Medical Center Haaglanden, location Westeinde Hospital
state: South Holland
city: Leidschendam
country: Netherlands
facility: Medical Center Haaglanden, location Antoniushove
state: South Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South Holland
city: Goes
country: Netherlands
facility: Oosterschelde Hospital
state: Zeeland
Study officials:
affiliation: Erasmus Medical Center
name: JAN Verhaar, PhD MD
role: STUDY_DIRECTOR
References:
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.