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Active, Not Recruiting

NCT Number: NCT05150925

Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate

The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teemu Karjalainen, Jyväskylä, Finland

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About this study

This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Intra- or extra articular DRF (Colles, Smith, Volar barton)
  • operative treatment justified

Exclusion criteria

  • Refusal to participate in the study
  • Open fracture with a severity greater than Gustilo grade 1
  • Patient aged less than 18 or over 65
  • Patient does not understand written or spoken guidance in local languages
  • Pathological fracture
  • Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
  • Ipsilateral fracture in upper extremity
  • Associated fractures of the ulna (except fractures of the PSU)
  • Polytrauma

Treatment and study plan

Cast treatment

Other

Dorsal cast placed in OR

Immediate mobilization

Other

Immediate mobilization postoperatively without casting

Volar plating

Procedure

Volar plating of distal radius fracture

Primary outcomes

  1. Patient-rated wrist evaluation questionnaire

    Time frame: 2 months

    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  2. Total lenght of the sick leave

    Time frame: 12 months

    Total number of days of work during the 1 year study period

Secondary outcomes

  1. Patient-rated wrist evaluation questionnaire

    Time frame: 4 weeks

    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  2. Patient-rated wrist evaluation questionnaire

    Time frame: 6 months

    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  3. Patient-rated wrist evaluation questionnaire

    Time frame: 12 months

    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  4. Return to work

    Time frame: 4 weeks

    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  5. Return to work

    Time frame: 2 months

    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  6. Return to work

    Time frame: 6 months

    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  7. Return to work

    Time frame: 12 months

    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  8. Complications

    Time frame: 4 weeks

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  9. Complications

    Time frame: 2 months

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  10. Complications

    Time frame: 6 months

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  11. Complications

    Time frame: 12 months

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  12. Self-perceived working ability

    Time frame: 4 weeks

    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  13. Self-perceived working ability

    Time frame: 2 months

    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  14. Self-perceived working ability

    Time frame: 6 months

    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  15. Self-perceived working ability

    Time frame: 12 months

    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  16. Visual analogue pain scale

    Time frame: 4 weeks

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  17. Visual analogue pain scale

    Time frame: 2 months

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  18. Visual analogue pain scale

    Time frame: 6 months

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  19. Visual analogue pain scale

    Time frame: 12 months

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  20. Patient-acceptable symptom state

    Time frame: 2 months

    Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

  21. Patient-acceptable symptom state

    Time frame: 6 months

    Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

  22. Patient-acceptable symptom state

    Time frame: 12 months

    Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

  23. Work capacity

    Time frame: 4 weeks

    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

  24. Work capacity

    Time frame: 2 months

    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

  25. Work capacity

    Time frame: 6 months

    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

  26. Work capacity

    Time frame: 12 months

    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

Other outcomes

  1. Patient activity

    Time frame: 4 weeks

    Patient activity measured with triaxial wrist accelerometer

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Danderyd Hospital
  • Jyväskylä Central Hospital
  • Kuopio University Hospital
  • Sundsvall Hospital

Registry information

Official study title

Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial

Acronym: LIMPER-DRF

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2021
Registry last updated
Feb 11, 2026

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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