Arthropathy of HandNCT05267964
Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty
A study testing Epping resection arthroplasty and CMC I prosthesis in people with Arthropathy of Hand, run by Medical University of Graz.
Trial summary
Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Hand
- What is being tested?
- Epping resection arthroplasty and CMC I prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification,
- failed conservative treatment prior to surgery,
- written informed consent to the study.
Who cannot join
- scaphotrapezotrapezoidal (STT) arthrosis,
- former CMC joint surgery,
- patients under custodianship.
About this study
Official title: Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty A Randomized Controlled Trial
Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)
Read the detailed description
The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome.
Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief.
Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.
- Conditions
- Arthropathy of Hand
- Being tested
- Epping resection arthroplasty, CMC I prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epping resection arthroplastyProcedure or surgery
Follwing the described epping resection arthroplasty, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.
CMC I prosthesisProcedure or surgery
Follwing the described CMC I prosthesis procedure, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Epping resection arthroplasty | Active comparator | During the Epping resection-suspension arthroplasty the trapeziectomy is performed, the flexor carpi radialis tendon is divided into two parts and one of these is stripped and cut proximally. To prevent shortening of the first ray with following loss of strength, this tendon strip is pulled through a drill hole in the base of the 1st metacarpal from ulnar palmar to radial dorsal. The rest of the tendon strip is sutured to a roll replacing the os trapezium. Receives: Procedure: Epping resection arthroplasty |
| CMC I prosthesis group | Active comparator | During implantation of the prosthesis the CMC joint is opened and 3 mm of the metacarpal base as well as osteophytes are resected. Following the release of the trapezium the first metacarpal and the trapezium are prepared for the prosthesis by broaching and drilling. After the test-implants have shown satisfying joint tension and anatomic conditions, the HA coated stem and cup are pressfit inserted in the appropriate size followed by the modular head. Receives: Procedure: CMC I prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome- Thumb opposition
Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji.
A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Measured: twelve months postoperative
Functional outcome - Thumb retropulsion
Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji
Measured: twelve months postoperative
Functional outcome - maximal palmar abduction
measurement of the maximal palmar abduction using a goniometer.
Measured: twelve months postoperative
Functional outcome - maximal radial abduction
measurement of the maximal radial abduction using a goniometer.
Measured: twelve months postoperative
Functional outcome - tip-to-tip force
The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands).
Measured: twelve months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Nov 2014
- Primary completion30 Nov 2019
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267964
- Sponsor's protocol ID
- 26-543 ex 13/14
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: IPD can be shared at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05267964
- Acronym / sponsor ID
- 26-543 ex 13/14
- Conditions
- Arthropathy of Hand
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)
Detailed description
The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome.
Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief.
Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epping resection arthroplasty | Active comparator | Procedure: Epping resection arthroplastyDuring the Epping resection-suspension arthroplasty the trapeziectomy is performed, the flexor carpi radialis tendon is divided into two parts and one of these is stripped and cut proximally. To prevent shortening of the first ray with following loss of strength, this tendon strip is pulled through a drill hole in the base of the 1st metacarpal from ulnar palmar to radial dorsal. The rest of the tendon strip is sutured to a roll replacing the os trapezium. |
| CMC I prosthesis group | Active comparator | Procedure: CMC I prosthesisDuring implantation of the prosthesis the CMC joint is opened and 3 mm of the metacarpal base as well as osteophytes are resected. Following the release of the trapezium the first metacarpal and the trapezium are prepared for the prosthesis by broaching and drilling. After the test-implants have shown satisfying joint tension and anatomic conditions, the HA coated stem and cup are pressfit inserted in the appropriate size followed by the modular head. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification,
- failed conservative treatment prior to surgery,
- written informed consent to the study.
Key exclusion criteria (3 listed)
- scaphotrapezotrapezoidal (STT) arthrosis,
- former CMC joint surgery,
- patients under custodianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epping resection arthroplastyFollwing the described epping resection arthroplasty, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy. | Procedure or surgery | Epping resection arthroplasty |
| CMC I prosthesisFollwing the described CMC I prosthesis procedure, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy. | Procedure or surgery | CMC I prosthesis group |
Primary outcome
Functional outcome- Thumb opposition
Time frame: twelve months postoperative
Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Functional outcome - Thumb retropulsion
Time frame: twelve months postoperative
Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji
Functional outcome - maximal palmar abduction
Time frame: twelve months postoperative
measurement of the maximal palmar abduction using a goniometer.
Functional outcome - maximal radial abduction
Time frame: twelve months postoperative
measurement of the maximal radial abduction using a goniometer.
Functional outcome - tip-to-tip force
Time frame: twelve months postoperative
The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: Undecided. IPD can be shared at reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Epping resection arthroplasty and CMC I prosthesis in people with Arthropathy of Hand, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome- Thumb opposition (time frame: twelve months postoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.