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Recruiting NCT07105657

The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments

Observational Hip Osteoarthritis Knee Osteoarthristis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rehabilitation.
Who it may be relevant to
Registry conditions: Hip Osteoarthritis, Knee Osteoarthristis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Patients with total hip or knee replacement experiencing persistant problems are offered 3 weeks of intensive rehabilitation.

Detailed description

Outcomes before, at the end of treatment and at 6 months follow up will be investigated. Data will be handled separately for the two groups of patients: 42 with a total hip replacement and 42 with a total knee replacement. Specific and generic outcomes will be collected.

Interventions

  • Other Rehabilitation
    Three weeks intensive rehabilitation where patients undergo group-based and individualised rehabilitation focusing at improving pain, function and quality of life for the patient

Primary outcome measures

  • HOOS/KOOS pain (0-100 score) [Time frame: Change from baseline (0) to 3 weeks]
  • HOOS/KOOS ADL (0-100 score) [Time frame: Change from baseline (0) to 3 weeks]
  • HOOS/KOOS quality of life (0-100 score) [Time frame: Change from baseline (0) to 3 weeks]
  • HOOS/KOOS pain (0-100 score) [Time frame: Change from 3 weeks to 7 months]
  • HOOS/KOOS ADL (0-100 score) [Time frame: Change from 3 weeks to 7 months]
  • HOOS/KOOS quality of life (0-100 score) [Time frame: Change from 3 weeks to 7 months]
  • Sit-to-stand test [Time frame: Change from baseline (0) to 3 weeks]
  • Sit-to-stand test [Time frame: Change from 3 weeks to 7 months]
Secondary outcome measures (12)
  • Patient acceptable symptom state (yes/no) [Time frame: 3 weeks follow up]
  • Patient acceptable symptom state (yes/no) [Time frame: 7 months follow up]
  • Pain catastrophising scale (0-52 score) [Time frame: Baseline]
  • Pain catastrophising scale (0-52 score) [Time frame: 3 weeks]
  • Pain catastrophising scale (0-52 score) [Time frame: 7 months]
  • Global rating of change (0-11 score) [Time frame: Change from baseline to 3 weeks]
  • Global rating of change (0-11 score) [Time frame: Change from baseline to 7 months]
  • The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale) [Time frame: Change from baseline (0) to 3 weeks]
  • The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale) [Time frame: Change from 3 weeks to 7 mothns]
  • EQ5D VAS (0-100 scale) [Time frame: Change from baseline (0) to 3 weeks]
  • EQ5D VAS (0-100 scale) [Time frame: Change from 3 weeks to 7 months]
  • HOOS/KOOS symptoms (0-100 score) [Time frame: Change from baseline (0) to 3 weeks]

Eligibility criteria

Inclusion criteria

\- Patients with a total hip or knee replacement admitted for intensive rehabilitation

Exclusion criteria

  • Patients unable to understand Danish
  • Unable to participate in physical tests
  • Unable to understand questionaires
  • Unable to participate i 6 months follow up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Horsens Regional Hospital — Brædstrup

Identifiers

NCT: NCT07105657 · 1-16-02-329-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗