Difficulty Walking Clinical Trial
Official title:
Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | RMC Groot Klimmendaal |
Netherlands,
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
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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