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NCT Number: NCT07105657

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

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

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Knee Osteoarthristis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Horsens Regional Hospital

Brædstrup, Denmark

Location status: Recruiting

Location contact

Signe Kierkegaard-Brøchner, PhD

CONTACT

[email protected]

004578427882

Signe Kierkegaard-Brøchner, PhD

PRINCIPAL_INVESTIGATOR

Stian Langgård Jørgensen, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

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 outcomes

  1. HOOS/KOOS pain (0-100 score)

    Time frame: Change from baseline (0) to 3 weeks

    Hip or knee related pain

  2. HOOS/KOOS ADL (0-100 score)

    Time frame: Change from baseline (0) to 3 weeks

    Hip or knee related activities of daily living

  3. HOOS/KOOS quality of life (0-100 score)

    Time frame: Change from baseline (0) to 3 weeks

    Hip or knee related quality of life

  4. HOOS/KOOS pain (0-100 score)

    Time frame: Change from 3 weeks to 7 months

    Hip or knee related pain

  5. HOOS/KOOS ADL (0-100 score)

    Time frame: Change from 3 weeks to 7 months

    Hip or knee related activities of daily living

  6. HOOS/KOOS quality of life (0-100 score)

    Time frame: Change from 3 weeks to 7 months

    Hip or knee related quality of life

  7. Sit-to-stand test

    Time frame: Change from baseline (0) to 3 weeks

    Number of completed sit to stands in 30 seconds

  8. Sit-to-stand test

    Time frame: Change from 3 weeks to 7 months

    Number of completed sit to stands in 30 seconds

Secondary outcomes

  1. Patient acceptable symptom state (yes/no)

    Time frame: 3 weeks follow up

    Patients are asked with a single question if their current symptom state is acceptable

  2. Patient acceptable symptom state (yes/no)

    Time frame: 7 months follow up

    Patients are asked with a single question if their current symptom state is acceptable

  3. Pain catastrophising scale (0-52 score)

    Time frame: Baseline

    Current level of pain catastrophising with 0 being the best

  4. Pain catastrophising scale (0-52 score)

    Time frame: 3 weeks

    Current level of pain catastrophising with 0 being the best

  5. Pain catastrophising scale (0-52 score)

    Time frame: 7 months

    Current level of pain catastrophising with 0 being the best

  6. Global rating of change (0-11 score)

    Time frame: Change from baseline to 3 weeks

    Likert scale where patients indicate their overall rating of change since the beginning of the intervention

  7. Global rating of change (0-11 score)

    Time frame: Change from baseline to 7 months

    Likert scale where patients indicate their overall rating of change since the beginning of the intervention

  8. The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)

    Time frame: Change from baseline (0) to 3 weeks

    EQ5D5L scores

  9. The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)

    Time frame: Change from 3 weeks to 7 mothns

    EQ5D5L scores

  10. EQ5D VAS (0-100 scale)

    Time frame: Change from baseline (0) to 3 weeks

    EQ5D Vas overall health

  11. EQ5D VAS (0-100 scale)

    Time frame: Change from 3 weeks to 7 months

    EQ5D Vas overall health

  12. HOOS/KOOS symptoms (0-100 score)

    Time frame: Change from baseline (0) to 3 weeks

    Hip or knee related symptoms

  13. HOOS/KOOS symptoms (0-100 score)

    Time frame: Change from 3 weeks to 7 months

    Hip or knee symptoms

  14. HOOS/KOOS sport/rec (0-100 score)

    Time frame: Change from baseline (0) to 3 weeks

    Hip or knee related sport/rec

  15. HOOS/KOOS sport/rec (0-100 score)

    Time frame: Change from 3 weeks to 7 months

    Hip or knee related sport/rec

  16. 6 minute walk test

    Time frame: Change from baseline (0) to 3 weeks

    The distance a patient can walk in 6 minutes

  17. 6 minute walk test

    Time frame: Change from 3 weeks to 7 months

    The distance a patient can walk in 6 minutes

  18. 40 meter fast paced walk test

    Time frame: Change from baseline (0) to 3 weeks

    The time a patient uses walking 40 meters fast

  19. 40 meter fast paced walk test

    Time frame: Change from 3 weeks to 7 months

    The time a patient uses walking 40 meters fast

  20. Stair test

    Time frame: Change from baseline (0) to 3 weeks

    The time a patient uses to ascend and decend a staircase

  21. Stair test

    Time frame: Change from 3 weeks to 7 months

    The time a patient uses to ascend and decend a staircase

Other outcomes

  1. Patient acceptable symptom state (yes/no)

    Time frame: Baseline

    Patients are asked with a single question if their current symptom state is acceptable

  2. Employment status (yes/no/part time)

    Time frame: Baseline

  3. Employment status (yes/no/part time)

    Time frame: 7 months

Study contacts

Contact information is provided by the study sponsor or research team.

Signe Kierkegaard-Brøchner, PhD

CONTACT

[email protected]

004578427882

Sponsors and collaborators

Lead sponsor

Horsens Hospital

Other

Collaborators

  • VIA University College

Registry information

Acronym: Rehab-hip-knee

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 26, 2025

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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