Trial document
This trial has been registered retrospectively.
DRKS00014808
Trial Description
Title
Influence of two surgical approaches on the postoperative course of recovery and the clinical outcome after total hip arthroplasty
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
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Brief Summary in Scientific Language
The prospective randomized controlled single-centre study compares the clinical outcome up to twelve months after total hip arthroplasty using a minimally invasive single-incision direct anterior (DAA) and a direct transgluteal lateral approach.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00014808
- 2018/05/31
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- yes
- Approved
- 72/11 , Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
Secondary IDs
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Health Condition or Problem studied
- M16 - Coxarthrosis [arthrosis of hip]
Interventions/Observational Groups
- hip arthroplasty using a minimally invasive anterior approach
- hip arthroplasty using a transgluteal lateral appraoch
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control (effective treament of control group)
- Treatment
- Parallel
- IV
- N/A
Primary Outcome
Patient activity as determined by the Stepwatch™ Activity Monitor preoperatively as well as 3, 6 and 12 months after surgery
Secondary Outcome
Secondary outcome measures include the
- Harris hip score (HHS)
- extra short musculoskeletal functional assessment questionnaire (XSMFA functional and bother index, 16 items)
- a timed 25 meter foot walk (T25-FW)
- and the short-form 36 questionnaire (SF-36 mental and physical component summaries).
The measurements are taken preoperatively and 6 weeks as well as three, six and twelve monthts after surgery.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2011/12/12
- 138
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 40 Years
- 80 Years
Additional Inclusion Criteria
primary osteoarthritis of the hip
Exclusion Criteria
age < 40 or > 80 years,
Body-Mass-Index (BMI) > 35 kg/m²,
hip dysplasia or a congenital disorder of the hip, former osteotomies of hip, knee or pelvis; an impairment of the contralateral side or osteoarthritis of the ipsilateral knee, osteoporosis, degenerative spine disease, or a severe systemic disease (ASA-Score ≥ 4, malignant or cardiovascular disease)
Addresses
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- Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität Würzburg
- Mr. Prof. Dr. med. habil. Ulrich Nöth
- Brettreichstr. 11
- 97074 Würzburg
- Germany
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- Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität Würzburg
- Mr. Dr. Dr. med. Johannes Reichert
- Brettreichstr. 11
- 97074 Würzburg
- Germany
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- j-reichert.klh at uni-wuerzburg.de
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- Orthopädische Klinik König-Ludwig-Haus
- Mr. Prof. Dr. med. habil. Ulrich Nöth
- Brettreichstr. 11
- 97074 Würzburg
- Germany
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- u-noeth.klh at uni-wuerzburg.de
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Sources of Monetary or Material Support
-
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- Deutsche Arthrose-Hilfe e.V.
- Postfach 11 05 51
- 60040 Frankfurt/Main
- Germany
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- http://www.arthrose.de
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Status
- Recruiting complete, follow-up complete
- 2014/03/31
Trial Publications, Results and other Documents
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