Condition category
Musculoskeletal Diseases
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.zimmer.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes