Outcomes of repeated surgery at the thumb base joint
| ISRCTN | ISRCTN16987734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16987734 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | OE-0112 |
| Sponsor | Schulthess Klinik |
| Funder | Schulthess Klinik |
- 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
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
Scientific
Lengghalde 2
Zurich
8008
Switzerland
 ORCID ID |
0000-0002-0623-2465 |
|---|---|
| Phone | +41443857581 |
| miriam.marks@kws.ch |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Ambidirectional monocenter research project consisting of a retrospective chart review and a prospective case series |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Outcomes of revision of thumb carpometacarpal joint (CMC I) arthroplasty |
| Study objectives | Patients 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) studied | Osteoarthritis of the CMC I joint |
| Intervention | This 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 type | Procedure/Surgery |
| Primary outcome measure(s) |
Level 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. |
| Key secondary outcome measure(s) |
1. 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. |
| Completion date | 13/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 27 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/06/2019 |
| Date of final enrolment | 13/11/2019 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Zurich
8008
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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).
