Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hip Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

Description

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 a...

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.

Tracking Information

NCT #
NCT04070027
Collaborators
  • Odense University Hospital
  • Naestved Hospital
  • Aarhus University Hospital
  • The Danish Rheumatism Association
  • Region of Southern Denmark
  • Association of Danish Physiotherapists
  • The Research Council at Naestved-Slagelse-Ringsted Hospitals
Investigators
Principal Investigator: Thomas Frydendal, PT, MSc Vejle Hospital and University of Southern Denmark Study Director: Søren Overgaard, Prof., MD Odense University Hospital and University of Southern Denmark Study Chair: Inger Mechlenburg, Prof., DMSc Aarhus University Hospital and Aarhus University Study Chair: Kim Gordon Ingwersen, PT, PhD Vejle Hospital and University of Southern Denmark Study Chair: Lone Ramer Mikkelsen, PT, PhD Silkeborg Regional Hospital Study Chair: Robin Christensen, Prof., PhD The Parker Institute and Odense University Hospital Study Chair: Claus Varnum, PhD, MD Vejle Hospital Study Chair: Henrik Morville Schrøder, PhD, MD Naestved Hospital