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Osteoarthritis, HipPhase 3NCT00391937

Efficacy of a New Resurfacing Hip Prosthesis

A Phase 3 study testing Articular Surface Replacement (ASR) hip prosthesis in people with Osteoarthritis, Hip, run by Erasmus Medical Center at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Osteoarthritis, Hip
What is being tested?
Articular Surface Replacement (ASR) hip prosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
6 sitesNetherlands
Study dates
Oct 2006to Jan 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Maxima Medical Center, location Eindhoven

    Eindhoven, North Brabant, 5600 PD

  • Oosterschelde Hospital

    Goes, Zeeland, 4462 RA

  • Medical Center Haaglanden, location Antoniushove

    Leidschendam, South Holland, 2260 AK

  • Laurentius Hospital

    Roermond, Limburg, 6043 CV

  • Erasmus Medical Center

    Rotterdam, South Holland, 3000 CA

  • Medical Center Haaglanden, location Westeinde Hospital

    The Hague, South Holland, 2501 CK

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Articular Surface Replacement (ASR) hip prosthesis
Keywords
"resurfacing hip" [MESH], "conventional position method", "surgery, computer-assisted" [MESH]
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Articular Surface Replacement (ASR) hip prosthesisDevice

    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.

Study groups in NCT00391937
Study groupRoleWhat they receive
1ExperimentalASR prosthesis placed using CAS
Receives: Device: Articular Surface Replacement (ASR) hip prosthesis
2Active comparatorASR prosthesis placed by conventional method
Receives: Device: Articular Surface Replacement (ASR) hip prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: within 8 weeks before surgery

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

    Measured: within one week after surgery

Secondary outcomes (8)

  1. Harris Hip Score

    Measured: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  2. Hip pain

    Measured: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  3. Assessments of the position of femoral component (biomechanical parameters) at the X-rays

    Measured: preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  4. Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

    Measured: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  5. Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)

    Measured: preoperatively and at 3 and 6 months postoperatively

  6. Quality of life

    Measured: preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively

  7. Early complications

    Measured: within 3 months after surgery

  8. Later complications

    Measured: longer than 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionFeb 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391937
Sponsor's protocol ID
06-DP-001
Status last verified
Feb 2013
First submitted
24 Oct 2006
Last updated
1 Mar 2013
Results posted
No

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.

    PubMed 31651318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Articular Surface Replacement (ASR) hip prosthesis in people with Osteoarthritis, Hip, run by Erasmus Medical Center at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pre planned position of the femoral component preoperatively (stem-shaft-angle) (time frame: within 8 weeks before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391937, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.

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