Influence of two surgical approaches on the postoperative course of recovery and the clinical outcome after total hip arthroplasty
Organizational Data
- DRKS-ID:
- DRKS00014808
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-05-31
- Last update in DRKS:
- 2018-05-31
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
No Entry
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.
Health condition or problem studied
- ICD10:
- M16 - Coxarthrosis [arthrosis of hip]
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- hip arthroplasty using a minimally invasive anterior approach
- Arm 2:
- hip arthroplasty using a transgluteal lateral appraoch
Endpoints
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Orthopädische Klinik König-Ludwig-Haus Würzburg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2011-12-12
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2014-03-31
- Target Sample Size:
- 138
- Final Sample Size:
- 148
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 40 Years
- Maximum Age:
- 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
Primary Sponsor
- Address:
- Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität WürzburgProf. Dr. med. habil. Ulrich NöthBrettreichstr. 1197074 WürzburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität WürzburgDr. Dr. med. Johannes ReichertBrettreichstr. 1197074 WürzburgGermany
- Telephone:
- 0931 8030
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Orthopädische Klinik König-Ludwig-HausProf. Dr. med. habil. Ulrich NöthBrettreichstr. 1197074 WürzburgGermany
- Telephone:
- 0931 8030
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Orthopädische Klinik König-Ludwig-Haus, Lehrstuhl für Orthopädie der Universität WürzburgDr. Dr. med. Johannes ReichertBrettreichstr. 1197074 WürzburgGermany
- Telephone:
- 0931 8030
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Deutsche Arthrose-Hilfe e.V.Postfach 11 05 5160040 Frankfurt/MainGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.arthrose.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und ToxikologieVersbacher Str. 997078 WürzburgGermany
- Telephone:
- +49-931-3148315
- Fax:
- +49-931-3187520
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2011-03-28
- Ethics committee number:
- 72/11
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2011-12-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry