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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02484781
Other study ID # LTC 2015-0576
Secondary ID
Status Completed
Phase N/A
First received June 9, 2015
Last updated July 14, 2016
Start date December 2015
Est. completion date December 2015

Study information

Verified date July 2016
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. It has been proposed as a treatment option for younger patients because of claims that it preserves femoral bone stock and has better functional outcomes. The assessment of gait after hip replacement surgery may be able to determine functional differences between patients who have undergone total hip replacement / arthroplasty (THA) versus hip resurfacing.


Description:

A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and kinematic parameters will be recorded.

- At first when flat walking with increasing speeds to their top walking speed.

- Secondly: when walking at a fixed speed with an increasing incline to their top walking incline.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Patient part of randomised controlled trial (RCT) of hip resurfacing versus MoM total hip arthroplasty for symptomatic osteoarthritis of the hip

- Patient must be able to consent to the study (written informed consent)

- Patients who are functioning well post-operatively and not under routine follow up

- Patients who are able to walk without any safety rail assistance on the treadmill

Exclusion Criteria:

- Patient not originally randomised during an RCT of hip resurfacing versus MoM total hip arthroplasty

- Patients who suffer from any neurological or musculoskeletal conditions that might make a gait test dangerous.

- Patients whose cognitive function prevents them from understanding the study

- Patients who have had or are awaiting revision surgery for their hip

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Intervention

Other:
Gait analysis on a trendmill
Gait analysis on a trendmill "GRAIL" to analyse spatio-temporal kinetics and kinematics when flat walking and inclining

Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Rijnstate Hospital RMC Groot Klimmendaal

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Aqil A, Drabu R, Bergmann JH, Masjedi M, Manning V, Andrews B, Muirhead-Allwood SK, Cobb JP. The gait of patients with one resurfacing and one replacement hip: a single blinded controlled study. Int Orthop. 2013 May;37(5):795-801. doi: 10.1007/s00264-013-1819-3. Epub 2013 Feb 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Top walking speed Mean top walking speed in kilometers / hour assessed on a trendmill 5 years postoperative No
Primary Walking cadence Mean steps / minute at top walking speed assessed on a trendmill 5 years postoperative No
Primary Step length Mean step distance in meters at top walking speed assessed on a trendmill 5 years postoperative No
Primary Maximum Push off force (N/kg) per cycle Mean ground reaction forces in Newton / kilogram on a trendmill 5 years postoperative No
Primary Maximum weight acceptance (N/kg) per cycle Mean ground reaction forces assessed on a trendmill 5 years postoperative No
Primary Mid-stance force (N/kg) per cycle Mean ground reaction forces assessed on a trendmill 5 years postoperative No
Primary Hip maximum flexion/extension per cycle Mean hip kinematics in degrees assessed on a trendmill 5 years postoperative No
Primary Hip maximum internal/external rotation per cycle Mean hip kinematics in degrees assessed on a trendmill 5 years postoperative No
Secondary Postoperative hip functionality after hip arthroplasty. Postoperative hip function according the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index 5 years postoperative No
Secondary General Health according EurQol-5D Health outcome on the EQ-5D questionairre 5 years postoperative No
Secondary Physical activity level according the UCLA-activity score The University of California at Los Angeles (UCLA) activity score 5 years postoperative No
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