Total Hip Arthroplasty
ProcedureTotal hip arthroplasty following standard procedures.
Other names: Total Hip Replacement
NCT Number: NCT04070027
Hip osteoarthritis is associated with joint pain, physical disability, decreased muscle strength and poor health status, and the most common cause for total hip arthroplasty. No studies have investigated the effect of total hip arthroplasty compared to non-surgical treatment in patients with end-stage hip osteoarthritis. This comparison is of upmost importance as it is unknown whether non-surgical treatment may be used as an alternate to surgery.
The purpose of this study is to investigate whether total hip arthroplasty followed by standard care is superior to progressive resistance training for improving hip function and pain in patients with end-stage hip osteoarthritis.
The hypothesis is that patients treated with total hip arthroplasty will improve more than patients treated with progressive resistance training.
This study is active but is not currently recruiting participants.
Notify Me50 year and older
All sexes
Interventional
Not applicable
Department of Orthopaedic Surgery, Aarhus University Hospital (AUH), Aarhus, Denmark
Hip osteoarthritis (OA) is associated with joint pain, dysfunction of activities of daily living (ADL), decreased muscle strength and decline in health-related quality of life status, and the most common cause for total hip arthroplasty (THA). In Denmark, approximately 10.400 primary THA surgeries are performed annually, and the yearly incidence rate of this procedure has increased dramatically from 80 to 180 per 100.000 persons between 1995 and 2016. However, some patients experience long-term pain and may never recover full physical function and muscle strength after surgery.
Exercise has been shown to improve physical function and reduce pain in people with hip OA, and is recommended initially as a treatment in international clinical guidelines. Furthermore, a recent randomised controlled trial (RCT) showed clinically relevant improvements in ADL and muscle function after 10-weeks of supervised explosive-type progressive resistance training (PRT) in patients with end-stage hip OA scheduled for THA compared to standard preoperative care.
To date, no RCTs have investigated the effect of THA followed by standard postoperative care compared to supervised explosive-type PRT in patients with end-stage hip OA. Therefore, this highlights the need for a high-quality trial as it is unknown whether non-surgical treatment may be used as an alternate to surgery.
The aim of this randomised controlled trial is to investigate whether THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the Oxford Hip Score (OHS), in patients with end-stage hip OA eligible for THA. Exploratory outcome time-points will be assessed at 3, 12, 24 and 60 months after initiating the intervention.
The hypothesis is that THA followed by standard care is superior to a 12-week supervised explosive-type PRT programme for improving patient-reported hip function and pain 6 months after initiating the intervention, measured using the OHS, in patients with end-stage hip OA eligible for THA.
Observational cohort:
Patients fulfilling the eligibility criteria but declining to participate in the RCT will be asked to participate in a prospective observational cohort study using the same primary end-point (6 months), exploratory time-points (3, 12, 24 and 60 months), and patient-reported outcomes, but following usual clinical practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total hip arthroplasty following standard procedures.
Other names: Total Hip Replacement
Progressive resistance training based on available evidence on patients with hip osteoarthritis and designed in accordance with the "American College of Sports Medicine" (ACSM) recommendations for progression models in resistance training aiming at inducing muscle hypertrophy and increasing muscle strength and power.
Other names: Strength Training, Exercise
Time frame: 6 months
The OHS is a 12-item patient-reported outcome measure designed to assess hip function and pain within the last four weeks among patients suffering from hip osteoarthritis in one score. The total score ranges from 0 to 48, with higher scores indicating better disease status.
Time frame: 6 months
The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess hip pain in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better pain status.
Time frame: 6 months
The HOOS pain subscale is a five-item patient-reported outcome measure designed to assess other hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptoms status.
Time frame: 6 months
The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status.
Time frame: 6 months
The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status.
Time frame: 6 months.
The HOOS sports and recreation subscale is a four-item patient-reported outcome measure designed to assess sports and recreation function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better sports and recreation status.
Time frame: 6 months
The UCLA Activity Score is a single-item patient-reported outcome measure designed to assess physical activity level. The score ranges from 1 to 10, with higher scores indicating greater physical activity level.
Time frame: 6 months
The 40m-FPWT is a physical function test designed to assess short distance maximum walking speed (meters/second).
Time frame: 6 months
The 30s-CST is a physical function test designed to assess sit-to-stand function (number of repetitions).
Time frame: 6 months.
SAE according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines will be collected from The Danish National Patient Registry and medical record review conducted at the 6 months follow-up. Furthermore, a short patient-reported questionnaire at the 3 and 6 months follow-up will be used to ensure that all SAE are recorded.
Time frame: 6 months
The VAS pain is a single-item patient-reported outcome measure used to assess mean hip pain intensity at rest, and main hip pain intensity activity during the previous 24 hours. The total scale ranges from 0 (no pain) to 100 (worst pain imaginable).
Time frame: 6 months
The EQ-5D-5L is a five-item patient-reported outcome measure designed to assess generic health-related quality-of-life. The total score of the descriptive index and EQ-VAS ranges from -0.624 (worst) to 1.000 (best) and 0 (worst imaginable health) to 100 (best imaginable health), respectively. This will also allow for a later cost-utility analysis.
Time frame: 6 months
Medicine consumption will be assessed with the following question: "Have you been taking pain medication within the last week?" on a dichotomous scale (yes/no). Patients answering "yes" will be asked to provide type of medication on a categorical scale (Paracetamol, NSAID, morphine/opioids, Gabapentin, and other), frequency on 6-point Likert-scale ranging from "1 time a week" to "4 times a day or above", and asked "Have you primarily been taking pain medication due to your hip?" rated on a dichotomous scale (yes/no). Patients responding "no" to the latter question will be asked "If no, have you been taking pain medication due to other known diseases or disorders?" rated on on a dichotomous scale (yes/no).
Time frame: 6 months
The GPE of the interventions will be assessed for seven domains, including overall hip problems, hip pain, hip symptoms, ADL function, sports and recreation, hip-related quality-of-life, and physical activity on a 15-point Likert scale ranging from "a very great deal worse" (worst) to "a very great deal better" (best).
Time frame: 6 months
PASS will be assessed with the following question: "When you think of your hip function, will you consider your current condition as satisfying?" By hip function, you should take into account your activities of daily living, sport and recreational activities, your hip pain and other symptoms and your quality-of-life on a dichotomous scale (yes/no).
Time frame: 6 months
Patient-reported treatment failure will be assessed only by patients answering "no" to PASS with the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?" on a dichotomous scale (yes/no).
Time frame: 6 months
Physical activity will be recorded with a tri-axial accelerometer (AX3, Axivity, Ltd., Newcastle, UK) mounted on the lateral thigh during a 7 day period. Data will be post-processed using a custom designed algorithm (MATLAB, Mathworks, Natick, MA, USA).
Time frame: 6 months
Isometric muscle strength of the index hip will be recorded for hip extension, flexion, and abduction with a handheld dynamometer (Commander Echo Wireless Console and Muscle Tester, JTECH Medical, Salt Lake City, Utah, USA) and reported as Newton meters per kilogram of the bodyweight (Nm/kg).
Time frame: 6 months
Number of total hip arthroplasty surgeries performed in the PRT group will be registered through a medical record review.
Time frame: 3 months
In the PRT group, the number of PRT sessions participated in by the patient will be registered by the supervising physiotherapist. High compliance will be defined as participation in ≥75% of the training sessions corresponding to 18 out of 24 sessions; moderate compliance as participation in 50-74% of the sessions; and poor compliance as participation in <50% of the sessions.
Time frame: 3 months
Training load of each exercise in the PRT group will be registered by the supervising physiotherapist and reported as kilogram (kg).
Time frame: 3 months
Following the 12-week supervised PRT program, adherence to three-months of optional unsupervised PRT will be measured by a patient-reported questionnaire.
Time frame: 6 months
Participation in postoperative supervised exercise in the THA group will be assessed using a patient-reported questionnaire.
Time frame: 6 months
Other treatments related to the index hip will be assessed using a patient-reported questionnaire.
Vejle Hospital
Other
Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With End-stage Hip Osteoarthritis (PROHIP): A Multicentre, Parallel-group, Randomised Controlled Superiority Trial
Acronym: PROHIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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