Influence of Femoral Head Size During Total Hip Arthroplasty on Gait
Study Details
Study Description
Brief Summary
Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size.
In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. There is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved.
The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Total hip replacement (THR) is being considered as one of the most effective medical procedures. Since its introduction, there was a worldwide debate over proper implant selection in terms of size, bearing type and shape. The diameter of used femoral heads components grew throughout the years - from 22 mm in the 1960s to 32 mm in the 2000s, which is the most commonly used size nowadays. In recent years there was a visible use of large femoral heads (>=36mm) in several registers. In the USA there was a significant grow in use of this heads rising from 1% in early 200s to even 58% in 2009. There is a strong evidence data and many researchers concerning range of movement, risk of dislocation, functional results, pain and prosthesis wear depending of femoral head size.
In terms of gait characteristics there are several deviations reported concerning both patients with hip osteoarthritis (OA) and following THR. It is well-proven that those with hip OA have reduced stride length and reduced cadence, reduced gait velocity, and reduced joint excursion. Patients after THR walk with lower hip-abduction moments, sagittal-plane range of motion. It is believed that it might be a consequence of pain-avoidance mechanism developed as an adaptation for joint disease, which is still present after the surgery. What is more, there are publications, which underline that lower limb biomechanics during gait do not return to normal following THR.
However there is a lack of literature concerning influence of used implants on gait parameters and whether this goal of the surgery can be achieved.
According to authors best knowledge this study is the first to ever describe potential differences in gait parameters between THR performed with standard femoral heads (28-32mm) and large ones (>=36mm).
Aim of the study The aim of this study was to assess potential differences of lower limb biomechanics during gait in patients following total hip replacement surgery depending on femoral head diameter and compare them to the normal gait of healthy volunteers. As a secondary outcome authors wanted to inspect correlation between gait parameters and patient-reported outcome.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Standard size femoral head implant Participants qualified to undergo total hip replacement who will receive standard femoral head size implant |
Procedure: Total hip replacement
Total hip replacement in treatment of end-stage osteoarthritis
|
| Active Comparator: Large size femoral head Participants qualified to undergo total hip replacement who will receive large femoral head size implant |
Procedure: Total hip replacement
Total hip replacement in treatment of end-stage osteoarthritis
|
Outcome Measures
Primary Outcome Measures
- Time of swing phase [at least 3,5 years after surgery]
Change from baseline part of swing phase time during gait, measured in percentage
- Time of stance phase [at least 3,5 years after surgery]
Change from baseline part of stance phase time during gait, measured in percentage
- Time of double-stance phase [at least 3,5 years after surgery]
Change from baseline part of double-stance phase time during gait, measured in percentage
- Stride length [at least 3,5 years after surgery]
Change from baseline length of stride during gait, measured in meters
- Cadence [at least 3,5 years after surgery]
Change from baseline number of strides per minute of walking
- Mean gait velocity [at least 3,5 years after surgery]
Change from baseline mean values of gait speed, measured in meters per second
- Range of maximal hip extension for both limbs during ending part of mid-stance phase [at least 3,5 years after surgery]
Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees
- Range of pelvic drop in frontal plane on the opposite site of the bearing limb [at least 3,5 years after surgery]
Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees
Eligibility Criteria
Criteria
Inclusion Criteria:
-
BMI <35
-
Ability to walk for 10 meters
-
60-80 years of age
-
Bilateral THR
Exclusion Criteria:
-
Revision surgeries before and after THR
-
Any other lower limbs surgeries
-
Secondary OA
-
Neurological disorders
-
Cardiac disorders
-
Severly impaired balance
-
Severe dizziness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Othopedics and Rehabilitation, Medical University of Warsaw | Warsaw | Poland |
Sponsors and Collaborators
- Medical University of Warsaw
Investigators
- Principal Investigator: Bartosz M. Maciąg, MD, Medical University of Warsaw
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WarsawMU/Head