Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications
1 other identifier
interventional
59
1 country
1
Brief Summary
The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications. The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by two minimal invasive/incision surgeries (MIS) versus the traditionally lateral approach. The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after MIS than after traditional lateral surgery. Patients in the MIS group will also be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 15, 2019
May 1, 2019
4.3 years
October 8, 2013
May 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant stability
2 years
Secondary Outcomes (1)
Implant stability
5 years
Study Arms (3)
direct lateral
ACTIVE COMPARATORminimal invasive
EXPERIMENTALmodified minimal invasive
EXPERIMENTALInterventions
Total hip replacement; modified minimal invasive approach
Eligibility Criteria
You may qualify if:
- Patients scheduled for THA
- Diagnosis of primary osteoarthritis as the main cause for elective THA
- American Society of Anesthesiologists (ASA) score I, II, and stable III
You may not qualify if:
- Musculoskeletal diseases
- Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St Olavs Hospital
Trondheim, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Jacob Stovner, prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 10, 2013
Study Start
August 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2018
Last Updated
May 15, 2019
Record last verified: 2019-05