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
Scientific
Academic Medical Centre
Department of Orthopedics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| m.j.veth@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Anatomy 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) studied | Total hip replacement (THR), arthritis |
| Intervention | Total hip arthroplasty: conventional lateral approach or two-incision anatomy sparing approach. |
| Intervention type | Other |
| 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 study start date | 01/11/2005 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 110 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Zimmer, Inc. (USA)
Industry
Industry
P.O. Box 708
1800 West Center Street
Warsaw, IN
46581-0708
United States of America
| Website | http://www.zimmer.com |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
