Minimally invasive surgery in total hip arthroplasty: the two-incision technique versus conventional total hip arthroplasty - a prospective, randomised, controlled trial

ISRCTN ISRCTN77525474
DOI https://doi.org/10.1186/ISRCTN77525474
Secondary identifying numbers NTR500
Submission date
09/01/2006
Registration date
09/01/2006
Last edited
03/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M J J Veth
Scientific

Academic Medical Centre
Department of Orthopedics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Email m.j.veth@amc.uva.nl

Study information

Study designMulticentre, randomised, controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesAnatomy sparing two-incision total hip arthroplasty (THA) has a better functional outcome than conventional THA.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedTotal hip replacement (THR), arthritis
InterventionTotal hip arthroplasty: conventional lateral approach or two-incision anatomy sparing approach.
Intervention typeOther
Primary outcome measureThe 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 measures1. 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 study start date01/11/2005
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants110
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2005
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Zimmer, Inc. (USA)
Industry

P.O. Box 708
1800 West Center Street
Warsaw, IN
46581-0708
United States of America

Website http://www.zimmer.com
ROR logo "ROR" https://ror.org/02bn55144

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan