Outcomes of repeated surgery at the thumb base joint

ISRCTN ISRCTN16987734
DOI https://doi.org/10.1186/ISRCTN16987734
Secondary identifying numbers OE-0112
Submission date
17/05/2019
Registration date
28/05/2019
Last edited
16/11/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Surgery for osteoarthritis of the thumb joint, such as trapeziecotmy (removal of a small bone in the wrist at the base of the thumb), leads to good results and high patient satisfaction. However, in some cases, repeated surgery is required due to persistent pain and restricted hand function. We aim to study the outcomes of this repeated surgery and to analyse the reasons for this surgery.

Who can participate?
All patients, who had a revision surgery at our center in the last 10 years will be invited for a follow-up consultation consisting of a clinical examination, radiographs and a questionnaire.

What does the study involve?
All patients who had a revision surgery of the CMC I joint between April 2009 and at least one year prior to examination will be eligible for participation and will be invited to a follow-up consultation. This consultation consists of a clinical examination, radiographs and a patient questionnaire.

What are the possible benefits and risks of participating?
Benefits: There is no compensation for participation. The increased scientific knowledge generated by this project will be primarily a gain for other patients seeking treatment for the same condition and will assist the surgeon in the decision-making process prior to surgery_
Risks: As patients will be invited for a follow-up examination, there is no intervention. The clinical examination and the completion of a patient subjective outcome questionnaire represent no more than minimum risk for project participants. At the follow-up examination, three radiographs of the thumb will be taken which are associated with low level of radiation of about 0.001 mSv (comparable to normal background radiation from less than a day according to www.webmd.com).

Where is the study run from?
Schulthess Klinik, Zurich, Switzerland.

When is the study starting and how long is it expected to run for?
June 2019 to October 2019

Who is funding the study?
Schulthess Klinik, Zurich, Switzerland.

Who is the main contact?
Dr Miriam Marks,
miriam.marks@kws.ch

Contact information

Dr Miriam Marks
Scientific

Lengghalde 2
Zurich
8008
Switzerland

ORCiD logoORCID ID 0000-0002-0623-2465
Phone +41443857581
Email miriam.marks@kws.ch

Study information

Study designAmbidirectional monocenter research project consisting of a retrospective chart review and a prospective case series
Primary study designObservational
Secondary study designCase series
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleOutcomes of revision of thumb carpometacarpal joint (CMC I) arthroplasty
Study objectivesPatients after CMC I revision surgery are in an acceptable pain state shown by a NRS score of ≤ 2.5 during daily activities.
Ethics approval(s)Approved 13/05/2019, Kantonale Ethikkommission Zürich (Cantonal ethics committee Zurich, Stampfenbachstrasse 121, 8090, Zürich, Switzerland; +41 (0) 43 259 79 70; Info.KEK@kek.zh.ch), ref: 2019-00569
Health condition(s) or problem(s) studiedOsteoarthritis of the CMC I joint
InterventionThis study solely consists of one consultation with a duration of approx. 45 min. After the patient provided written informed consent, the patient will undergo a clinical examination including radiographs. The clinical examination includes measures of range of motion (ROM), grip and pinch strength and radiographs. Afterwards, the patient will complete a questionnaire on a tablet PC, which data will be stored in a REDCap database. All data from the clinical measures will be entered directly into the REDCap project database by the doctor.
Intervention typeProcedure/Surgery
Primary outcome measureLevel of pain. If patients are in a Patient Acceptable Symptom State (PASS) regarding pain during activities measured on a Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain). The PASS is defined as an NRS score of ≤ 2.5.
Secondary outcome measures1. Range of Motion measured using flexion and extension of the MCP and thumb Interphalangeal (IP) joint will be measured with a goniometer. The evaluation of active thumb opposition is based on the Kapandji index, ranging from 1 to 1026. Patients try to touch their fingers with the tip of the thumb. The score is 1 when patients are able to touch only the lateral side of the index finger and 10 when they can reach the volar crease of the hand.
2. Grip strength measured using a JAMAR dynamometer.
3. Key pinch measured using a pinch gauge.
4. Radiographs. If radiographs of before primary surgery are available, OA severity will be graded from stage I (normal articular contours with joint widening due to ligament laxity) to stage IV (complete thumb CMC joint deterioration and narrowed, sclerotic scaphotrapezial joint) based on the Eaton classification. At follow-up, three radiographic views of the affected hand (anterior-posterior, lateral and oblique) to assess the trapezial space ratio will be taken and the trapezial space ratio will be calculated.
5. Hand function measured using the Brief Michigan Hand Outcomes Questionnaire (MHQ).
6. Satisfaction measured using two additional questions about satisfaction in the consultation.
7. Sociodemographic and disease-related data which will be extracted from the medical records: Age, gender, diagnosis, date and type of primary and revision surgery/surgeries, indication for primary and revision surgery/surgeries, affected side, date of diagnosis, complications after primary and revision surgery/surgeries, other surgeries performed in the same session (e.g. carpal tunnel release), clinical data (range of motion, strength).
8. Adverse events that had been occurred during or after primary and revision surgery will be extracted out of the medical records and patients will be asked about additional events not documented in the medical records.
Overall study start date01/01/2019
Completion date13/11/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Total final enrolment27
Key inclusion criteria1. Patient with any type of revision surgery at the CMC I join
2. Revision surgery between 1 and 10 years before the follow-up examination
3. Primary surgery consisted of any type of resection arthroplasty or implant arthroplasty
4. Informed consent as documented by signature
Key exclusion criteria1. Major surgery at another joint at the same hand (e.g. PIP arthroplasty, DIP arthrodesis) less than 6 months before the examination
2. Legal incompetence
3. Cannot read or write German language to complete the questionnaires
Date of first enrolment01/06/2019
Date of final enrolment13/11/2019

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Schulthess Klinik
Lengghalde 2
Zurich
8008
Switzerland

Sponsor information

Schulthess Klinik
Hospital/treatment centre

Lengghalde 2
Zurich
8008
Switzerland

Phone +41 44 385 75 81
Email miriam.marks@kws.ch
Website www.schulthess-klinik.ch
ROR logo "ROR" https://ror.org/01xm3qq33

Funders

Funder type

Hospital/treatment centre

Schulthess Klinik

No information available

Results and Publications

Intention to publish date30/11/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planAbstracts for SGH ans FESSH conferences 2020
Full paper will be submitted to JHS Eur in 2020
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 20/10/2021 16/11/2021 Yes No

Editorial Notes

16/11/2021: Publication reference added.
14/09/2021: The intention to publish date has been changed from 30/09/2021 to 30/11/2021.
15/06/2021: The intention to publish date has been changed from 31/12/2020 to 30/09/2021.
10/12/2019: The overall trial end date has been changed from 31/12/2019 to 13/11/2019.
20/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2019 to 13/11/2019.
2. The total final enrolment was added.
23/05/2019: Trial’s existence confirmed by Kantonale Ethikkommission Zürich (Cantonal ethics committee Zurich).