Condition category
Musculoskeletal Diseases
Date applied
07/02/2017
Date assigned
14/02/2017
Last edited
16/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and affects millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. In some, movement can be limited so severely that they need to use walking aids such as crutches to get around. Using forearm walking aids (crutches that attach at the forearm) often leads to pain in the forearms. Special handles called anatomic handles have been developed to increase the size of the contact area and reduce the pressure, but for many this is ineffective. One third of the load is transferred via the forearm. In contrast to the hand, the ulnar (outer, lower arm bone) is not well protected and this can often lead to compression of the ulna nerve, leading to pain. This study aims to look at the effectiveness of a newly developed anatomic cuff for forearm crutches which aims to protect the ulnar bone and distributing the load towards surrounding muscles and soft tissue.

Who can participate?
Patients with OA who have used forearm crutches on both sides for at least eight weeks.

What does the study involve?
All participants are given the special crutches with the anatomic cuff to use for four weeks. The length of the crutches is adjusted depending on participant height. At the start of the study and then after four weeks, participants complete questionnaires to assess their forearm pain and general helath.

What are the possible benefits and risks of participating?
Participants may benefit from lower pain levels in their forearms than if they used conventional crutches. There are no notable risks involved with participating.

Where is the study run from?
University Hospital Basel (Switzerland)

When is the study starting and how long is it expected to run for?
January 2014 to December 2016

Who is funding the study?
University Hospital Basel (Switzerland)

Who is the main contact?
Professor Thomas Hügle
thomas.huegle@unibasl.ch

Trial website

Contact information

Type

Public

Primary contact

Prof Thomas Hügle

ORCID ID

Contact details

University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2014/1

Study information

Scientific title

Prospective clinical evaluation of a novel anatomic cuff for forearm crutches in patients with osteoarthritis

Acronym

Study hypothesis

Anatomic cuffs with ulnar protection are less associated with pain and discomfort in long-term users of forearm crutches.

Ethics approval

Ethikkomission beider Basel (EKBB) Switzerland, 03/06/2014, ref: E350/12

Study design

Prospective non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Osteoarthritis

Intervention

At baseline, all participants receive forearm crutches with an anatomic cuff (Ulnar Pro®, Rebotec, Quakenbrück, Germany) with anatomic hand grip (model soft, Rebotec, Quakenbrück, Germany) to use for four weeks. The length of the crutches are adjusted by the study team to the patients’ hand height during stance with the arms positioned at 20 to 30° elbow flexion. Clinical data are collected at baseline and at 4-weeks follow-up using questionnaires.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Pain along the forearm is measured using a questionnaire based on a unipolar 9-point Likert-scale designed for the purpose of this study at baseline and 4 weeks

Secondary outcome measures

General health is assessed using 36-Item Short Form Survey (SF-36) at baseline and 4 weeks

Overall trial start date

01/01/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Suffering from osteoarthritis
2. Have used bilateral forearm crutches for at least 8 weeks prior to the study

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Infections of hands or forearms
2. Amputation
3. Neuropathy (e.g. due to diabetes or syringomyely)
4. Active rheumatic diseases
5. Upper limp injuries

Recruitment start date

01/03/2014

Recruitment end date

01/10/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Petersgraben 4
Basel
4045
Switzerland

Sponsor information

Organisation

University Hospital Basel

Sponsor details

Petersgraben 4
Basel
4031
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Thomas.huegle@unibas.ch

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28292295

Publication citations

Additional files

Editorial Notes

16/03/2017: Publication reference added.