Postoperative Therapy After Interposition Arthroplasty in CMC1

Thumb Osteoarthritis Clinical Trial

Official title:

Postoperative Therapy After Interposition Arthroplasty in CMC1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01679717
• Other study ID #: H4/2012
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2012
• Last updated: May 4, 2015
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Diakonhjemmet Hospital
• Contact: Tove Nilsen, MSc
• Phone: +47 22451500
• Email: tove.nilsen[@]diakonsyk.no
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Norway	Diakonhjemmet hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	The Norwegian Women´s Public Health Association

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Training diary	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.	Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.	No
Primary	Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.	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.	Baseline, 3, 6 and 12 months	No
Primary	Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.	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).	Baseline, 3, 6 and 12 months	No
Secondary	Measure for activity performance (MAP-hand).	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.	Baseline, 3, 6 and 12 months	No
Secondary	Grip force and pinch grip	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.	Baseline, 3, 6 and 12 months	No
Secondary	Joint mobility	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.	Baseline, 3, 6 and 12 months	No
Secondary	Pain	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.	Baseline, 3, 6, and 12 months	No