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The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

Rosenlund S, Broeng L, Jensen C, Holsgaard-Larsen A, Overgaard S - BMC Musculoskelet Disord (2014)

Bottom Line: Follow-up will also be performed after three and six months.The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L).Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.

View Article: PubMed Central - PubMed

Affiliation: Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. signe.rosenlund@gmail.com.

ABSTRACT

Background: Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year.

Methods/design: The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45-70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.

Discussion: To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up.

Trial registration: Clinicaltrial.gov: NCT01616667.

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Related in: MedlinePlus

Study flow chart.
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Fig1: Study flow chart.

Mentions: Balanced 1:1 block randomisation was performed using a computer-generated list containing a sequence of one letter and one number; "A" referring the patient to posterior approach, "B" referring the patient to lateral approach. "1" referring the patient to participate in the gait analysis and thus contributing with data on GDI, and "0" referring the patient not to participate in the gait analysis (FigureĀ 1). Four blocks of 20 patients each was generated. The sequence was generated by a third person (JL) not involved in the trial. The letter and number combination was written on paper, folded and placed in sealed opaque consecutively numbered envelopes. The booking secretary will open the envelopes in the given order, and according to the content the patient will be scheduled for operation. In the first three blocks there will be a 66% chance of being allocated to group 1(gait analysis). This will enable us to verify the sample size calculation of 2x20 patients for the GDI. A recompilation will be made, based on ungrouped results of GDI for the 20 first actual gait analyses performed. From this, we will adjust the final number of patients allocated to gait analysis accordingly.Figure 1


The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol.

Rosenlund S, Broeng L, Jensen C, Holsgaard-Larsen A, Overgaard S - BMC Musculoskelet Disord (2014)

Study flow chart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4216831&req=5

Fig1: Study flow chart.
Mentions: Balanced 1:1 block randomisation was performed using a computer-generated list containing a sequence of one letter and one number; "A" referring the patient to posterior approach, "B" referring the patient to lateral approach. "1" referring the patient to participate in the gait analysis and thus contributing with data on GDI, and "0" referring the patient not to participate in the gait analysis (FigureĀ 1). Four blocks of 20 patients each was generated. The sequence was generated by a third person (JL) not involved in the trial. The letter and number combination was written on paper, folded and placed in sealed opaque consecutively numbered envelopes. The booking secretary will open the envelopes in the given order, and according to the content the patient will be scheduled for operation. In the first three blocks there will be a 66% chance of being allocated to group 1(gait analysis). This will enable us to verify the sample size calculation of 2x20 patients for the GDI. A recompilation will be made, based on ungrouped results of GDI for the 20 first actual gait analyses performed. From this, we will adjust the final number of patients allocated to gait analysis accordingly.Figure 1

Bottom Line: Follow-up will also be performed after three and six months.The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L).Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.

View Article: PubMed Central - PubMed

Affiliation: Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. signe.rosenlund@gmail.com.

ABSTRACT

Background: Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year.

Methods/design: The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45-70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.

Discussion: To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up.

Trial registration: Clinicaltrial.gov: NCT01616667.

Show MeSH
Related in: MedlinePlus