Contact information
Type
Scientific
Primary contact
Dr M J J Veth
ORCID ID
Contact details
Academic Medical Centre
Department of Orthopedics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
m.j.veth@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR500
Study information
Scientific title
Acronym
Study hypothesis
Anatomy sparing two-incision total hip arthroplasty (THA) has a better functional outcome than conventional THA.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Total hip replacement (THR), arthritis
Intervention
Total hip arthroplasty: conventional lateral approach or two-incision anatomy sparing approach.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The purpose of the study is to scientifically determine the functional effectiveness of anatomy sparing surgery in total hip arthroplasty in comparison with traditional open surgery, measured by the Harris Hip Score.
Secondary outcome measures
1. Number of virtual admission days. Virtual is defined as the number of days until the patient is ready for discharge in the opinion of the surgeon and the patient. Any additional days due to logistic circumstances are not included in this main objective. Virtual discharge criteria are:
1.1. Function, measured in: 50 m walking, walking 1 stairs, getting in and out of bed
1.2. Pain (Visual Analogue Scale [VAS] cm function)
1.3. Wound assessment: including effusion and aspect
2. The Western Ontario and McMaster Universities Osteoarthritis Index
3. Visual Analogue Scale (VAS) is used to measure severity of pain during different activities
4. Use of analgesics
5. The 36-item Short Form Health Survey (SF-36) (pre-operative and at 1 year follow-up)
6. Patient satisfaction
7. Total operation time
8. Number and kind of complications (including wound infection, wound haematoma, dislocations)
9. Need for blood transfusion
10. Wound aspect during treatment period
Overall trial start date
01/11/2005
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female being 18 years or older
2. Patients meet the criteria for osteoarthritis:
2.1. Pain in hip
2.2. Arthritic changes on radiograph: joint space narrowing femoral/acetabular osteofytes
3. Patients not responding to conservative therapy
4. Written informed consent for study participation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant exclusion criteria
1. Patients who are mentally impaired and not able to fill in questionnaires
2. Patients who do not know the Dutch language
3. Patients with a body mass index (BMI) of more than 40
4. Patients with skeletal immaturity
5. Patients with a life expectancy of less than 3 years
6. Patients with altered anatomy resulting in impossibility for the MIS procedure, according to the surgeon e.g.:
6.1. Hip dysplasia with high luxation
6.2. Post-traumatic severe anatomy change
6.3. Post-correction osteotomy
7. Patients with extremity amputation
8. Patients with an active malignant disease or current cytostatic treatment
9. Patients who are participating in another trial
10. Known alcohol or drug abuse
Recruitment start date
01/11/2005
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Zimmer, Inc. (USA)
Sponsor details
P.O. Box 708
1800 West Center Street
Warsaw
IN
46581-0708
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list