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Hip surgical techniques to enhance rehabilitation

HIP Surgical Techniques to Enhance Rehabilitation - a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27974201
Enrollment
339
Registered
2023-09-19
Start date
2023-10-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip surgery Surgery

Interventions

Current interventions as of 10/09/2024: This is a single-centre, double-blind, parallel three-arm, randomised-controlled, superiority trial of patients undergoing Total hip replacement surgery. The

Sponsors

Royal Devon University Healthcare NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients with osteoarthritis of the hip 2. Patients suitable for a cementless acetabular component 3. Patients over the age of 18 years 4. Patients of any Body Mass Index (BMI) 5. Patients willing and able to provide informed consent in English

Exclusion criteria

Exclusion criteria: 1. Patients with active systemic or local infection that would preclude standard THR surgery 2. Patients undergoing bilateral THR in same operative episode 3. Patients unable to give informed consent 4. Patients unable or unwilling to take part in the trial process, including patients unable to undertake activity monitoring data collection or complete the PROMS questionnaires in English (English is the only common translation available in official translations of all six PROMS)

Design outcomes

Primary

MeasureTime frame
Pain, sleep, nausea and feeling unwell, and mobility, are measured using the Oxford Arthroplasty Early Recovery Score (OARS) at 6 weeks post-operatively.

Secondary

MeasureTime frame
1. Muscle damage and inflammation are measured using serum creatinine kinase (CK) and C-reactive protein (CRP) blood biomarkers at the pre-operative assessment, day 0/1, and at 6 weeks post-operatively. 2. Walking and sleep quality are measured using activity monitors to collect 2 weeks of continuous data at the pre-operative assessment, and 6 weeks, 6 months, and 12 months post-operatively. 3. Patient perspective on their treatment is measured using the Oxford Arthroplasty Early Change Score (OACS) at 6 weeks post-operatively. 4. Pain and function are measured using the Oxford Hip Score (OHS) at the pre-operative assessment, and 6 weeks, 6 months, and 12 months, post-operatively. 5. Function is measured using the Lower Extremity Functional Scale (LEFS) at the pre-operative assessment, and 6 weeks, 6 months, and 12 months post-operatively. 6. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression are measured using the EQ-5D-5L questionnaire at the pre-operative assessment, and 6 weeks, 6 months, and 12 months post-operatively. 7. Patient satisfaction is measured using the Self-Administered Patient Satisfaction Scale (SAPS) at 6 weeks, 6 months, and 12 months post-operatively. 8. Clinical outcomes: ‘duration of surgery’, ‘blood loss’, and ‘length of hospital stay’ are recorded during and immediately after surgery. 9. Additional analgesia use (not included as part of standard care) is recorded during the first 6 weeks post-operatively. 10. The safety of approaches is measured by recording adverse events from the day of surgery until 12 months post-operatively.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026