Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip Arthroplasty, an Exploratory Study

NCT02484781 | Completed

• 1 other identifier: LTC 2015-0576
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Difficulty Walking; Gait, Stumbling

Keywords

Gait disorder; Resurfacing Hip Arthroplasty; Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (8)

• Top walking speed

  Mean top walking speed in kilometers / hour assessed on a trendmill

  5 years postoperative

• Walking cadence

  Mean steps / minute at top walking speed assessed on a trendmill

  5 years postoperative

• Step length

  Mean step distance in meters at top walking speed assessed on a trendmill

  5 years postoperative

• Maximum Push off force (N/kg) per cycle

  Mean ground reaction forces in Newton / kilogram on a trendmill

  5 years postoperative

• Maximum weight acceptance (N/kg) per cycle

  Mean ground reaction forces assessed on a trendmill

  5 years postoperative

• Mid-stance force (N/kg) per cycle

  Mean ground reaction forces assessed on a trendmill

  5 years postoperative

• Hip maximum flexion/extension per cycle

  Mean hip kinematics in degrees assessed on a trendmill

  5 years postoperative

• Hip maximum internal/external rotation per cycle

  Mean hip kinematics in degrees assessed on a trendmill

  5 years postoperative

Secondary Outcomes (3)

• Postoperative hip functionality after hip arthroplasty.

  5 years postoperative

• General Health according EurQol-5D

  5 years postoperative

• Physical activity level according the UCLA-activity score

  5 years postoperative

Study Arms (2)

Total Hip Arthroplasty

ACTIVE COMPARATOR

Gait analysis on a trendmill of patients with a well functioning total hip arthroplasty on a trendmill

Other: Gait analysis on a trendmill

Resurfacing Hip Arthroplasty

ACTIVE COMPARATOR

Gait analysis on a trendmill of patients with a well functioning resurfacing hip arthroplasty on a trendmill

Other: Gait analysis on a trendmill

Interventions

Gait analysis on a trendmill OTHER

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

Also known as: Gait realtime analysis interactive lab: MOTEK Medical

Resurfacing Hip Arthroplasty; Total Hip Arthroplasty

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• RMC Groot Klimmendaal: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800WC, Netherlands

Location

Related 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.

  PMID: 23443980 BACKGROUND

MeSH Terms

Conditions

Mobility Limitation; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Job LC Susante, Dr

  Rijnstate Hospital, orthopedic surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. JLC van Susante

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 30, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

NL (1)