Carpometacarpal; DislocationDislocationNCT04668794
Carpometacarpal Fracture-dislocations
An observational study of Carpometacarpal; Dislocation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Fracture-dislocation of the carpometacarpal (CMC) joints of the ring and little finger are the most affected CMC joints and the dislocation may be accompanied by other hand injuries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpometacarpal; Dislocation
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2020to 14 Nov 2022
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients are adults with a closed injury in their hand. For clinical, x-ray and TC we evaluated the carpometacarpal fracture dislocation of the hand and associated lesions.
Who may be able to join
- Closed carpometacarpal fracture dislocation of the hand
- Adults from 18 to 80 years old
Who cannot join
- history of fractures or tendon lesions in the same hand
- Children
- Open fracture dislocations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carpometacarpal Fracture-dislocation of the Hand: Interobserver and Intraobserver Variability for Identify Associate Hamate Fractures and Its Implications in Surgical Planning and Treatment
Fracture-dislocation of the carpometacarpal (CMC) joints of the ring and little finger are the most affected CMC joints and the dislocation may be accompanied by other hand injuries. Fracture-dislocation of the CMC joints of the ring and little finger are extremely mobile because of their saddle shape anatomy and loose ligamentous attachments. Missed and incorrect diagnosis is very frequent in metacarpal base injuries of the hand and results in impaired function and weak grip. In these lesions immediate reduction is imperative. Treatment options for these injuries include non-operative management, closed reduction with Kirschner wire fixation (K-wire) and open reduction with internal fixation (ORIF). In chronic CMC fracture-dislocations ORIF is mandatory. Although operative treatment is recommended in the literature in fracture-dislocation of the CMC joints of the ring and little finger, other authors, in specific cases, performed conservative treatment through immediate reduction and splint immobilization and this treatment can be sufficient.
Read the detailed description
Physical examination in carpometacarpal injuries reveals ulnar-sided pain, swelling, diffuse edema, a palpable lump and tenderness of the hand.
Radiological examination include hand-wrist radiographs in the posteroanterior (PA), true lateral and 45º oblique views. A true lateral view of the hand may demonstrate the dislocation, although overlapping of the joints can mask the dislocation. On PA radiographs, Fisher et al. propose using the so-called M-line parallelism of the CMC joints. A break in this M-line suggests a dislocation. Another method is to draw metacarpal cascade lines on a PA radiographs.
It is important to recognise the associate lesions, for example hamate fractures, because this fracture can change the prognosis, surgical planning and treatment. The investigators hypothesized that there is an interobserver variability to evaluate the carpometacarpal fracture-dislocation and associated lesions in x-rays are underestimated. The investigators propose a protocol with a CT scan to asses this lesions. The researchers hypothesised that surgical reconstruction would result in better clinical result and lower complications rate than non-surgical treatment.
- Conditions
- Carpometacarpal; Dislocation
- Being tested
- Osteosynthesis
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Also called Cast
Reduction and fixation of the carpometacarpal fracture dislocation of the hand with osteosynthesis (Kirschners wires, plate and screws)
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamate fracture
Hamate fracture associated with the dislocation of the fifth and fourth finger. Cain´s classification for the description of fracture-dislocation. Milch´s classification for hamate fractures types.
Measured: 6 months
Degree of displacement
Degree of displacement (% displacement) in X-rays and CT scan.
Measured: 6 months
Intrarticular stepoff and degenerative osteoarthritis
Intrarticular stepoff (mm) and sclerosis, cysts, osteophytes, joint space reduction (mm) in X-rays and CT scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start2 Nov 2020
- Primary completion10 Oct 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carpometacarpal; DislocationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Lamas, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668794
- Sponsor's protocol ID
- IIBSP-FLC-2020-29
- Acronym
- Dislocation
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Retrospective study that observe the x-rays and TC scan and the results of the surgical or conservative treatment.
Publications
Kural C, Basaran SH, Ercin E, Bayrak A, Bilgili MG, Baca E. Fourth and fifth carpometacarpal fracture dislocations. Acta Orthop Traumatol Turc. 2014;48(6):655-60. doi: 10.3944/AOTT.2014.14.0040.
PubMed 25637730Gehrmann SV, Kaufmann RA, Grassmann JP, Logters T, Schadel-Hopfner M, Hakimi M, Windolf J. Fracture-dislocations of the carpometacarpal joints of the ring and little finger. J Hand Surg Eur Vol. 2015 Jan;40(1):84-7. doi: 10.1177/1753193414562706.
PubMed 25538072Mueller JJ. Carpometacarpal dislocations: report of five cases and review of the literature. J Hand Surg Am. 1986 Mar;11(2):184-8. doi: 10.1016/s0363-5023(86)80048-x.
PubMed 3958446Henderson JJ, Arafa MA. Carpometacarpal dislocation. An easily missed diagnosis. J Bone Joint Surg Br. 1987 Mar;69(2):212-4. doi: 10.1302/0301-620X.69B2.3818751.
PubMed 3818751Kjaer-Petersen K, Jurik AG, Petersen LK. Intra-articular fractures at the base of the fifth metacarpal. A clinical and radiographical study of 64 cases. J Hand Surg Br. 1992 Apr;17(2):144-7. doi: 10.1016/0266-7681(92)90075-d.
PubMed 1588193Cobb WA, Dingle L, Zarb Adami R, Rodrigues J. Management of fracture-dislocations of the little finger carpometacarpal joint: a systematic review. J Hand Surg Eur Vol. 2018 Jun;43(5):530-538. doi: 10.1177/1753193417752317. Epub 2018 Feb 7.
PubMed 29411672Storken G, Bogie R, Jansen EJ. Acute ulnar carpometacarpal dislocations. Can it be treated conservatively? A review of four cases. Hand (N Y). 2011 Dec;6(4):420-3. doi: 10.1007/s11552-011-9347-3. Epub 2011 Jul 7. No abstract available.
PubMed 23204970Fisher MR, Rogers LF, Hendrix RW. Systematic approach to identifying fourth and fifth carpometacarpal joint dislocations. AJR Am J Roentgenol. 1983 Feb;140(2):319-24. doi: 10.2214/ajr.140.2.319.
PubMed 6600352Hodgson PD, Shewring DJ. The 'metacarpal cascade lines'; use in the diagnosis of dislocations of the carpometacarpal joints. J Hand Surg Eur Vol. 2007 Jun;32(3):277-81. doi: 10.1016/J.JHSB.2006.09.020.
PubMed 17331628Fa-Binefa M, Almenara M, Mata-Munoz JM, Gich-Saladich I, Llauger J, Lamas C. Retrospective interobserver agreement on diagnoses of 4th and 5th carpometacarpal fracture-dislocation and hamate fracture in plain X-ray - Is CT essential after ulnar carpometacarpal pain? Skeletal Radiol. 2023 Dec;52(12):2427-2433. doi: 10.1007/s00256-023-04366-9. Epub 2023 May 25.
PubMed 37227483
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpometacarpal Fracture-dislocation of the Hand: Interobserver and Intraobserver Variability for Identify Associate Hamate Fractures and Its Implications in Surgical Planning and Treatment
- ClinicalTrials.gov ID
- NCT04668794
- Acronym / sponsor ID
- Dislocation / IIBSP-FLC-2020-29
- Conditions
- Carpometacarpal; Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 16 Dec 2020 (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.
Fracture-dislocation of the carpometacarpal (CMC) joints of the ring and little finger are the most affected CMC joints and the dislocation may be accompanied by other hand injuries. Fracture-dislocation of the CMC joints of the ring and little finger are extremely mobile because of their saddle shape anatomy and loose ligamentous attachments. Missed and incorrect diagnosis is very frequent in metacarpal base injuries of the hand and results in impaired function and weak grip. In these lesions immediate reduction is imperative. Treatment options for these injuries include non-operative management, closed reduction with Kirschner wire fixation (K-wire) and open reduction with internal fixation (ORIF). In chronic CMC fracture-dislocations ORIF is mandatory. Although operative treatment is recommended in the literature in fracture-dislocation of the CMC joints of the ring and little finger, other authors, in specific cases, performed conservative treatment through immediate reduction and splint immobilization and this treatment can be sufficient.
Detailed description
Physical examination in carpometacarpal injuries reveals ulnar-sided pain, swelling, diffuse edema, a palpable lump and tenderness of the hand.
Radiological examination include hand-wrist radiographs in the posteroanterior (PA), true lateral and 45º oblique views. A true lateral view of the hand may demonstrate the dislocation, although overlapping of the joints can mask the dislocation. On PA radiographs, Fisher et al. propose using the so-called M-line parallelism of the CMC joints. A break in this M-line suggests a dislocation. Another method is to draw metacarpal cascade lines on a PA radiographs.
It is important to recognise the associate lesions, for example hamate fractures, because this fracture can change the prognosis, surgical planning and treatment. The investigators hypothesized that there is an interobserver variability to evaluate the carpometacarpal fracture-dislocation and associated lesions in x-rays are underestimated. The investigators propose a protocol with a CT scan to asses this lesions. The researchers hypothesised that surgical reconstruction would result in better clinical result and lower complications rate than non-surgical treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients are adults with a closed injury in their hand. For clinical, x-ray and TC we evaluated the carpometacarpal fracture dislocation of the hand and associated lesions.
Key inclusion criteria (2 listed)
- Closed carpometacarpal fracture dislocation of the hand
- Adults from 18 to 80 years old
Key exclusion criteria (3 listed)
- history of fractures or tendon lesions in the same hand
- Children
- Open fracture dislocations
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 |
|---|---|---|
| OsteosynthesisAlso: CastReduction and fixation of the carpometacarpal fracture dislocation of the hand with osteosynthesis (Kirschners wires, plate and screws) | Procedure or surgery | – |
Primary outcome
Hamate fracture
Time frame: 6 months
Hamate fracture associated with the dislocation of the fifth and fourth finger. Cain´s classification for the description of fracture-dislocation. Milch´s classification for hamate fractures types.
Degree of displacement
Time frame: 6 months
Degree of displacement (% displacement) in X-rays and CT scan.
Intrarticular stepoff and degenerative osteoarthritis
Time frame: 6 months
Intrarticular stepoff (mm) and sclerosis, cysts, osteophytes, joint space reduction (mm) in X-rays and CT scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Results publication: PubMed 25637730Kural C, Basaran SH, Ercin E, Bayrak A, Bilgili MG, Baca E. Fourth and fifth carpometacarpal fracture dislocations. Acta Orthop Traumatol Turc. 2014;48(6):655-60. doi: 10.3944/AOTT.2014.14.0040.
- Results publication: PubMed 25538072Gehrmann SV, Kaufmann RA, Grassmann JP, Logters T, Schadel-Hopfner M, Hakimi M, Windolf J. Fracture-dislocations of the carpometacarpal joints of the ring and little finger. J Hand Surg Eur Vol. 2015 Jan;40(1):84-7. doi: 10.1177/1753193414562706.
- Results publication: PubMed 3958446Mueller JJ. Carpometacarpal dislocations: report of five cases and review of the literature. J Hand Surg Am. 1986 Mar;11(2):184-8. doi: 10.1016/s0363-5023(86)80048-x.
- Results publication: PubMed 3818751Henderson JJ, Arafa MA. Carpometacarpal dislocation. An easily missed diagnosis. J Bone Joint Surg Br. 1987 Mar;69(2):212-4. doi: 10.1302/0301-620X.69B2.3818751.
- Results publication: PubMed 1588193Kjaer-Petersen K, Jurik AG, Petersen LK. Intra-articular fractures at the base of the fifth metacarpal. A clinical and radiographical study of 64 cases. J Hand Surg Br. 1992 Apr;17(2):144-7. doi: 10.1016/0266-7681(92)90075-d.
- Results publication: PubMed 29411672Cobb WA, Dingle L, Zarb Adami R, Rodrigues J. Management of fracture-dislocations of the little finger carpometacarpal joint: a systematic review. J Hand Surg Eur Vol. 2018 Jun;43(5):530-538. doi: 10.1177/1753193417752317. Epub 2018 Feb 7.
- Results publication: PubMed 23204970Storken G, Bogie R, Jansen EJ. Acute ulnar carpometacarpal dislocations. Can it be treated conservatively? A review of four cases. Hand (N Y). 2011 Dec;6(4):420-3. doi: 10.1007/s11552-011-9347-3. Epub 2011 Jul 7. No abstract available.
- Results publication: PubMed 6600352Fisher MR, Rogers LF, Hendrix RW. Systematic approach to identifying fourth and fifth carpometacarpal joint dislocations. AJR Am J Roentgenol. 1983 Feb;140(2):319-24. doi: 10.2214/ajr.140.2.319.
- Results publication: PubMed 17331628Hodgson PD, Shewring DJ. The 'metacarpal cascade lines'; use in the diagnosis of dislocations of the carpometacarpal joints. J Hand Surg Eur Vol. 2007 Jun;32(3):277-81. doi: 10.1016/J.JHSB.2006.09.020.
- Derived from this study: PubMed 37227483Fa-Binefa M, Almenara M, Mata-Munoz JM, Gich-Saladich I, Llauger J, Lamas C. Retrospective interobserver agreement on diagnoses of 4th and 5th carpometacarpal fracture-dislocation and hamate fracture in plain X-ray - Is CT essential after ulnar carpometacarpal pain? Skeletal Radiol. 2023 Dec;52(12):2427-2433. doi: 10.1007/s00256-023-04366-9. Epub 2023 May 25.
- Individual participant dataSharing planned: No. Retrospective study that observe the x-rays and TC scan and the results of the surgical or conservative treatment.
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.
Claudia Lamas, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpometacarpal; Dislocation, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hamate fracture (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04668794, which also lists 10 linked publications.
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 8 Mar 2023.