No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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: -function, measured in: -50m walking, -walking 1 stairs, -getting in and out of bed-Pain (VAS icm function)-Wound assessment: incl. effusion + aspect
-The Western Ontario and McMaster Universities Osteoarthritis Index
-Visual Analogue Scale (VAS) is used to measure severity of pain during different activities. (Corianne kijkt hoe pijnmedicatie en VAS-score te combineren)
Use of analgesics.
-The SF-36 (pre-operative and at 1 year follow-up)
-Patient satisfaction (Corianne: zijn verschillende mogelijkheden)
-Total operation time.
-Number and kind of complications (incl wound infection, wound haematoma, dislocations (main objective gebaseerd op funtionele uitkomst, compl dus geen effect!)
-Need for blood transfusion.
-Wound aspect during treatment period.
Background summary
N/A
Study objective
anatomy sparing 2-incision total hip arthroplasty (THA) has a better functional outcome than conventional THA.
Intervention
Total hip arthroplasty: conventional lateral approach or 2-incision anatomy sparing approach.
Department of Orthopedics,
P.O. Box 22660
M.J.J. Veth
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
m.j.veth@amc.uva.nl
Department of Orthopedics,
P.O. Box 22660
M.J.J. Veth
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
m.j.veth@amc.uva.nl
Inclusion criteria
1. Male or female being 18 years or older;
2. Patients meet the criteria for osteoarthritis:
a. Pain in hip;
b. Arthritic changes on radiograph:
joint space narrowing femoral / acetabular osteofytes;
3. Patients not responding to conservative therapy;
4. Written informed consent for study participation.
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 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.:
a. Hip dysplasia with high luxation
b. Post traumatic severe anatomy change
c. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL459 |
| NTR-old | NTR500 |
| Other | : N/A |
| ISRCTN | ISRCTN77525474 |