Postoperative Therapy After Interposition Arthroplasty in CMC1

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Diakonhjemmet Hospital
Sponsor:
Collaborator:
The Norwegian Women´s Public Health Association
Information provided by (Responsible Party):
Tove Nilsen, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01679717
First received: August 23, 2012
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

In this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a faster recovery of hand function. The investigators also want to explore patients' satisfaction with the two different treatment regimes. The participants in the control group will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. The participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. A total of 70 patients will be included in the study.


Condition Intervention
Thumb Osteoarthritis
Other: Early mobilisation after CMC1-surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Therapy After Interposition Arthroplasty in CMC1

Resource links provided by NLM:


Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months. [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.

  • Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months. [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).


Secondary Outcome Measures:
  • Measure for activity performance (MAP-hand). [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    MAP-hand is a questionnaire consisting of questions about 18 standardised activities. The patients will be instructed to score their ability to perform the activities on a scale from 1(No difficulty)to 4 (Not able to do). The Norwegian version of the MAP-hand has been tested for validity, reliability and responsiveness.

  • Grip force and pinch grip [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The electronical instrument Grippit will be used to measure grip force and pinch grip. In Grippit, force recordings in Newtons (N) are displayed on the electronic unit every 0.5 seconds over a period of 10 seconds. The peak and average of the 20 registrations, as well as the final value (last recording) will be recorded.

  • Joint mobility [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    • The flexion deficit of fingers 2 - 5 will be assessed by measuring the distance between the distal nail and the proximal crease inside the hand in millimeters.
    • Range of motion in the thumbs metacarpophalangeal and interphalangeal joints will be measured with a goniometer.
    • The palmar abduction of the CMC1 and of the entire thumb will be measured with the Pollexograph.

  • Pain [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Pain will be measured on a numeric rating scale (NRS), (0-10, 0=no pain), by asking the patients to mark the level of pain experienced both while they are resting and during resisted motion when measuring grip force and pinch grip.


Other Outcome Measures:
  • Training diary [ Time Frame: Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months. ] [ Designated as safety issue: No ]
    The patients will be asked to report which date they performed exercises, which exercises they performed and how much pain they experienced after performing the exercises. They will also be encouraged to write down their own comments /reflections regarding the training.


Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early mobilisation after CMC1-surgery
Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.
Other: Early mobilisation after CMC1-surgery
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.
Conservative treatment after CMC1-surgery
Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.
Other: Early mobilisation after CMC1-surgery
Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
  • Planned surgery(interposition arthroplasty) in CMC1
  • Ability to communicate in Norwegian

Exclusion Criteria:

  • Surgery involving other joints of the hand in addition to CMC1.
  • Previous surgery of the same thumb.
  • Other diseases og injuries that could influence hand function.
  • Mental or cognitive deficit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679717

Contacts
Contact: Tove Nilsen, MSc +47 22451500 tove.nilsen@diakonsyk.no
Contact: Ingvild Kjeken, PhD +47 22451500 ingvild.kjeken@diakonsyk.no

Locations
Norway
Diakonhjemmet hospital Recruiting
Oslo, Norway, N-0370
Contact: Tove Nilsen, MSc    +47 22451500    tove.nilsen@diakonsyk.no   
Contact: Ingvild Kjeken, PhD    +47 22451500    ingvild.kjeken@diakonsyk.no   
Principal Investigator: Tove Nilsen, MSc         
Sponsors and Collaborators
Diakonhjemmet Hospital
The Norwegian Women´s Public Health Association
Investigators
Study Chair: Ingvild Kjeken, Ph.d Department of Rheumatology, Diakonhjemmet hospital
  More Information

No publications provided

Responsible Party: Tove Nilsen, Occupational therapist MSc, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01679717     History of Changes
Other Study ID Numbers: H4/2012
Study First Received: August 23, 2012
Last Updated: September 3, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Diakonhjemmet Hospital:
Osteoarthritis
CMC1-joint
Postoperative therapy
Interposition arthroplasty of the thumb
Occupational therapy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014