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 |
| Protocol serial number | NTR500 |
| Sponsor | Zimmer, Inc. (USA) |
| Funder | Not provided at time of registration |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Academic Medical Centre
Department of Orthopedics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| m.j.veth@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
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: |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
