Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip

NCT02308813 | Completed

• 1 other identifier: 503/2014BO2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with hip osteoarthritis and patients who have received total hip arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.

Conditions

Osteoarthritis; Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Correlation of an index of manual reaction time combined with functional hip tests and braking performance

  Evaluation of degree of correlation of braking performance (total brake response time) and clinical testing of hip functionality in patients with hip osteoarthritis or total hip arthroplasty. The measure is a composite measure of multiple different tests. If a sufficient correlation between the composite measure and braking performance is observed a regression model will be developed. One time point of evaluation for each participant.

  Osteoarthritis group: cross sectional at consultation, Total hip arthroplasty group: cross-sectional - from 5 weeks postoperatively until 400 months postoperatively, at consultation

Study Arms (2)

Braking and functionality with hip osteoarthritis

EXPERIMENTAL

Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with hip osteoarthritis

Other: Braking and functionality

Braking and functionality with hip arthroplasty

EXPERIMENTAL

Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with total hip arthroplasty

Other: Braking and functionality

Interventions

Braking and functionality OTHER

Braking and functionality with hip arthroplasty; Braking and functionality with hip osteoarthritis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• valid driving license
• male and female
• Hip Osteoarthritis, Total hip arthroplasty
• capability to walk with or without a walking stick

You may not qualify if:

• myocardial infarction/Apoplexia \< 6 months
• Total hip arthroplasty \<5 weeks
• New York Heart Association 3/4
• lacking drivers' license
• peripheric sensomotor deficit \<3/5 British Medical Research Council
• new fracture of the lower extremity or spine
• systemic or metastasised Cancer
• drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Til

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Department of Orthopaedics

Tübingen, 72076, Germany

Location

Related Publications (1)

• Hau R, Csongvay S, Bartlett J. Driving reaction time after right knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2000;8(2):89-92. doi: 10.1007/s001670050192.

  PMID: 10795670 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ulf K Hofmann, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: December 4, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2014-11

Locations

DE (1)