Finger Joint DeformitiesNCT07921927
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
A study testing Relative Motion Flexion (RMF) orthosis intervention group in people with Finger Joint Deformities and Tendon Injuries, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Boutonnière injuries involve damage to the central slip of the extensor tendon over the proximal interphalangeal (PIP) joint (zone III) of the finger. These injuries disrupt the balance of the extensor mechanism, leading to volar displacement of the lateral bands and progressive development of Boutonnière deformity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Finger Joint Deformities, Tendon Injuries, Hand Injuries
- What is being tested?
- Relative Motion Flexion (RMF) orthosis intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- persons with acute and subacute closed injurt to the central slip/extensor tendon zon 3
- positive pencil test
Who cannot join
- open injury or infection
- joint contracture >20
- trauma >1 year ago
- previous trauma or surgery in the same finger
- simultaneous crush injury
- concomitant fracture and/or digital nerve injury and/or flexor tendon injury
- rheumatoid arthritis
- drug abuse, sever cognitive impairment, or severe psychological disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elisabeth Brogren, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital (Hand Surgery Rehabilitation Unit)
Malmö, Skåne County, 205 02
Ulrika Wijk, PhD, +46 40 331744, ulrika.wijk@med.lu.se
About this study
Official title: Conservative Treatment With Relative Motion Flexion (RMF) Orthosis for Boutonniere Injuries
Boutonnière injuries involve damage to the central slip of the extensor tendon over the proximal interphalangeal (PIP) joint (zone III) of the finger. These injuries disrupt the balance of the extensor mechanism, leading to volar displacement of the lateral bands and progressive development of Boutonnière deformity, characterized by PIP joint flexion and distal interphalangeal (DIP) joint hyperextension. Due to the gradual onset and closed nature of the injury, diagnosis is often delayed, and untreated cases may result in joint contractures, reduced range of motion (ROM), pain, and functional limitations.
Treatment is typically conservative and requires prolonged immobilization and splinting, often followed by dynamic orthoses such as Capener splints. However, evidence supporting current treatment strategies is limited and clinical outcomes are variable. Recently, the Relative Motion Flexion (RMF) orthosis has been introduced as an alternative approach aimed at restoring extensor mechanism balance. Existing evidence is limited to small or heterogeneous studies, highlighting the need for further evaluation.
Read more
This pilot study aims to assess the feasibility and preliminary effects of RMF orthosis treatment in patients with Boutonnière injuries. The primary objective is to evaluate changes in finger range of motion (ROM) and to estimate variability and within-subject correlations to inform sample size calculations for a future randomized controlled trial. Additional feasibility outcomes include recruitment rate, adherence to treatment, and practicality of measurement procedures.
Secondary objectives include evaluating pain, grip strength, functional hand limitations in daily activities, and patient-reported tolerability and comfort of the orthosis.
The study will be conducted as a prospective longitudinal cohort pilot study with repeated within-subject measurements at baseline, 3 months, and 12 months. A total of 25 adult patients with acute or subacute closed zone III extensor tendon injuries will be recruited consecutively at the Hand Surgery Rehabilitation Unit, Skåne University Hospital, Malmö.
Inclusion criteria include age ≥18 years, positive pencil test, and confirmed central slip injury. Exclusion criteria include open injuries, significant joint contractures (>20°), chronic injuries (>1 year), previous surgery or trauma in the same finger, concomitant fractures or tendon/nerve injuries, inflammatory arthropathies, and severe cognitive or psychiatric conditions or substance abuse.
All participants will receive treatment with an RMF orthosis according to a structured protocol consisting of 6 weeks of continuous use followed by 6 weeks of intermittent daytime and nighttime use. No separate control group will be included; analyses will be based on within-subject comparisons over time.
Primary outcome is ROM measured at the MCP, PIP, and DIP joints using a goniometer. Secondary outcomes include pain (Numeric Rating Scale), grip strength (Jamar dynamometer), hand function (QuickDASH), adherence and tolerability questionnaires, and recruitment rate.
Data will be analyzed using descriptive statistics and nonparametric longitudinal methods, including Friedman tests and Wilcoxon signed-rank tests for paired comparisons across time points.
The study will be conducted in accordance with the Declaration of Helsinki, with ethical approval sought from the Swedish Ethical Review Authority. All participants will provide informed consent, and data will be pseudonymized in accordance with GDPR. The study poses minimal risk, and participants will be monitored throughout treatment with adjustments made as needed.
This pilot study will generate essential data on treatment variability, feasibility, and preliminary outcomes of RMF orthosis use. The results will inform the design of a future randomized controlled trial and may contribute to improved evidence-based management of Boutonnière injuries, potentially leading to better functional outcomes and more efficient rehabilitation strategies.
Read the detailed description
Boutonnière injuries involve disruption of the central slip of the extensor tendon over the proximal interphalangeal (PIP) joint (zone III) of the finger. This leads to imbalance in the extensor mechanism, with volar displacement of the lateral bands and progressive development of Boutonnière deformity, characterized by PIP flexion and compensatory DIP hyperextension. Due to the often gradual onset and closed injury mechanism, diagnosis is frequently delayed. If untreated, the condition may result in stiffness, joint contractures, pain, reduced range of motion (ROM), and long-term functional impairment.
Current conservative treatment typically consists of prolonged immobilization of the PIP joint in extension, followed by dynamic orthotic management. Although widely used, evidence supporting existing treatment strategies is limited and outcomes are variable. Treatment is often demanding for patients due to prolonged splinting and restricted hand function during rehabilitation.
The Relative Motion Flexion (RMF) orthosis has been introduced as an alternative treatment strategy aimed at restoring balance within the extensor mechanism while allowing greater functional use of the hand during rehabilitation. However, current evidence is limited to small case series, heterogeneous cohorts, and studies with methodological limitations. Further prospective evaluation is therefore needed.
This study is designed as a prospective longitudinal pilot cohort study with repeated within-subject measurements. The primary purpose is to evaluate feasibility and to generate parameters required for planning a future randomized controlled trial, including estimates of variability in range of motion outcomes and within-subject correlations over time.
The study will also explore preliminary effects of RMF orthosis treatment on finger range of motion, as well as secondary outcomes including pain, grip strength, functional hand limitations, and patient-reported tolerability and adherence.
A total of 25 adult patients with acute or subacute closed central slip injuries (zone III) will be recruited consecutively at the Hand Surgery Rehabilitation Unit, Skåne University Hospital, Malmö, Sweden.
Participants will be treated with an RMF orthosis according to a structured rehabilitation protocol consisting of 6 weeks of continuous use followed by 6 weeks of intermittent use during daytime and nighttime. Treatment is delivered as part of routine rehabilitation follow-up, with adjustments made as clinically indicated.
Outcomes will be assessed at baseline, 3 months, and 12 months after treatment initiation. Primary outcome is range of motion (ROM) measured at the MCP, PIP, and DIP joints using a goniometer. Secondary outcomes include pain intensity (Numeric Rating Scale), grip strength (Jamar dynamometer), hand function (QuickDASH), and a study-specific questionnaire assessing adherence and tolerability. Recruitment rate will be recorded as number of eligible patients included per month.
As a pilot study, no control group is included. Analyses will focus on within-subject changes over time and estimation of parameters needed for sample size calculation in a future randomized controlled trial. Data will be analyzed using descriptive statistics and nonparametric longitudinal methods, including Friedman tests and Wilcoxon signed-rank tests for paired comparisons across time points.
The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval will be sought from the Swedish Ethical Review Authority (Etikprövningsmyndigheten). Written informed consent will be obtained from all participants. All data will be pseudonymized and handled in accordance with applicable data protection regulations (GDPR). The study involves minimal risk, and participants will be monitored throughout the rehabilitation period.
This pilot study will provide essential feasibility data and preliminary clinical outcomes for RMF orthosis treatment. The results will inform the design of a future randomized controlled trial and may contribute to improved evidence-based management of Boutonnière injuries, with the potential to enhance functional recovery and optimize rehabilitation strategies.
- Conditions
- Finger Joint Deformities, Tendon Injuries, Hand Injuries, Extensor Tendons of Finger Anomalies
- Being tested
- Relative Motion Flexion (RMF) orthosis intervention group
- Keywords
- Boutonniere injury, Boutonniere deformity, extensor tendon injury, finger injury, conservative treatment, relative motion orthosis
- Medical subject headings
- Tendon Injuries, Hand Injuries, Hapnes Boman Skeie syndrome, Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative Motion Flexion (RMF) orthosis intervention groupOther
The intervention consists of treatment with a Relative Motion Flexion (RMF) orthosis for patients with Boutonnière injuries of the finger (zone III extensor tendon injuries). The orthosis is applied according to a structured rehabilitation protocol consisting of 6 weeks of continuous wear, followed by 6 weeks of intermittent use during daytime and nighttime. The aim of the intervention is to restore extensor mechanism balance while allowing functional use of the hand during rehabilitation. Participants receive standard follow-up at the hand surgery rehabilitation unit, with adjustments made as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Relative Motion Flexion (RMF) orthosis intervention group | Experimental | Participants in this arm receive treatment with a Relative Motion Flexion (RMF) orthosis as part of a structured rehabilitation protocol. The intervention consists of 6 weeks of continuous orthosis use followed by 6 weeks of intermittent use during daytime and nighttime. No control intervention is used, and outcomes are assessed longitudinally within the same participants over time. Receives: Other: Relative Motion Flexion (RMF) orthosis intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range Of Motion (ROM)
Range of Motion in each joint MCP, PIP, DIP
Measured: baseline, 3 months, 12 months
Range of motion (ROM)
Active range of motion assessed with a finger goniometer
Measured: baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Finger Joint DeformitiesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- his is a single-group longitudinal pilot study with repeated within-subject measurements. All participants receive the same intervention (Relative Motion Flexion orthosis), and outcomes are assessed at multiple time points (baseline, 3 months, and 12 months) to evaluate changes over time. No control group is included; each participant serves as their own control.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921927
- Sponsor's protocol ID
- no grant number assigned
- Other IDs
- Region Skåne FoU funding
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be publicly shared. De-identified data may be available upon reasonable request and ethical approval.
Publications
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Arslan OB, Sigirtmac IC, Ayvali C, Bas CE, Ayhan E, Bilgin SS, Oksuz C. The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. J Hand Surg Am. 2024 May;49(5):488.e1-488.e8. doi: 10.1016/j.jhsa.2022.08.007. Epub 2022 Oct 4.
PubMed 36202676Merritt WH, Jarrell K. A Paradigm Shift in Managing Acute and Chronic Boutonniere Deformity: Anatomic Rationale and Early Clinical Results for the Relative Motion Concept Permitting Immediate Active Motion and Hand Use. Ann Plast Surg. 2020 Mar;84(3S Suppl 2):S141-S150. doi: 10.1097/SAP.0000000000002307.
PubMed 32028337Johnson C, Swanson M, Manolopoulos K. Treatment of a zone III extensor tendon injury using a single relative motion with dorsal hood orthosis and a modified short arc motion protocol-A case report. J Hand Ther. 2021 Jan-Mar;34(1):135-141. doi: 10.1016/j.jht.2019.03.014. Epub 2019 May 10.
PubMed 31080073Merritt WH, Wong AL, Lalonde DH. Recent Developments Are Changing Extensor Tendon Management. Plast Reconstr Surg. 2020 Mar;145(3):617e-628e. doi: 10.1097/PRS.0000000000006556.
PubMed 32097332Geoghegan L, Wormald JCR, Adami RZ, Rodrigues JN. Central slip extensor tendon injuries: a systematic review of treatments. J Hand Surg Eur Vol. 2019 Oct;44(8):825-832. doi: 10.1177/1753193419845311. Epub 2019 May 1.
PubMed 31042102Fox PM, Chang J. Treating the Proximal Interphalangeal Joint in Swan Neck and Boutonniere Deformities. Hand Clin. 2018 May;34(2):167-176. doi: 10.1016/j.hcl.2017.12.006.
PubMed 29625636Merritt W. The relative motion concept in acute and chronic boutonniere deformity: Invited commentary. J Hand Ther. 2023 Apr-Jun;36(2):258-268. doi: 10.1016/j.jht.2023.02.005. Epub 2023 Apr 10.
PubMed 37045641Carl HD, Forst R, Schaller P. Results of primary extensor tendon repair in relation to the zone of injury and pre-operative outcome estimation. Arch Orthop Trauma Surg. 2007 Feb;127(2):115-9. doi: 10.1007/s00402-006-0233-3. Epub 2006 Sep 30.
PubMed 17013604van Strien G, van Zwieten KJ. An in-depth look at zone III and IV anatomy of the finger extensor mechanism and some clinical implications for use of the relative motion flexion orthosis. J Hand Ther. 2023 Apr-Jun;36(2):280-293. doi: 10.1016/j.jht.2023.01.002. Epub 2023 Apr 20.
PubMed 37085432
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment With Relative Motion Flexion (RMF) Orthosis for Boutonniere Injuries
- ClinicalTrials.gov ID
- NCT07921927
- Acronym / sponsor ID
- no grant number assigned
- Conditions
- Finger Joint Deformities, Tendon Injuries, Hand Injuries, Extensor Tendons of Finger Anomalies
- Keywords
- Boutonniere injury, Boutonniere deformity, extensor tendon injury, finger injury, conservative treatment, relative motion orthosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
Boutonnière injuries involve damage to the central slip of the extensor tendon over the proximal interphalangeal (PIP) joint (zone III) of the finger. These injuries disrupt the balance of the extensor mechanism, leading to volar displacement of the lateral bands and progressive development of Boutonnière deformity, characterized by PIP joint flexion and distal interphalangeal (DIP) joint hyperextension. Due to the gradual onset and closed nature of the injury, diagnosis is often delayed, and untreated cases may result in joint contractures, reduced range of motion (ROM), pain, and functional limitations.
Treatment is typically conservative and requires prolonged immobilization and splinting, often followed by dynamic orthoses such as Capener splints. However, evidence supporting current treatment strategies is limited and clinical outcomes are variable. Recently, the Relative Motion Flexion (RMF) orthosis has been introduced as an alternative approach aimed at restoring extensor mechanism balance. Existing evidence is limited to small or heterogeneous studies, highlighting the need for further evaluation.
This pilot study aims to assess the feasibility and preliminary effects of RMF orthosis treatment in patients with Boutonnière injuries. The primary objective is to evaluate changes in finger range of motion (ROM) and to estimate variability and within-subject correlations to inform sample size calculations for a future randomized controlled trial. Additional feasibility outcomes include recruitment rate, adherence to treatment, and practicality of measurement procedures.
Secondary objectives include evaluating pain, grip strength, functional hand limitations in daily activities, and patient-reported tolerability and comfort of the orthosis.
The study will be conducted as a prospective longitudinal cohort pilot study with repeated within-subject measurements at baseline, 3 months, and 12 months. A total of 25 adult patients with acute or subacute closed zone III extensor tendon injuries will be recruited consecutively at the Hand Surgery Rehabilitation Unit, Skåne University Hospital, Malmö.
Inclusion criteria include age ≥18 years, positive pencil test, and confirmed central slip injury. Exclusion criteria include open injuries, significant joint contractures (>20°), chronic injuries (>1 year), previous surgery or trauma in the same finger, concomitant fractures or tendon/nerve injuries, inflammatory arthropathies, and severe cognitive or psychiatric conditions or substance abuse.
All participants will receive treatment with an RMF orthosis according to a structured protocol consisting of 6 weeks of continuous use followed by 6 weeks of intermittent daytime and nighttime use. No separate control group will be included; analyses will be based on within-subject comparisons over time.
Primary outcome is ROM measured at the MCP, PIP, and DIP joints using a goniometer. Secondary outcomes include pain (Numeric Rating Scale), grip strength (Jamar dynamometer), hand function (QuickDASH), adherence and tolerability questionnaires, and recruitment rate.
Data will be analyzed using descriptive statistics and nonparametric longitudinal methods, including Friedman tests and Wilcoxon signed-rank tests for paired comparisons across time points.
The study will be conducted in accordance with the Declaration of Helsinki, with ethical approval sought from the Swedish Ethical Review Authority. All participants will provide informed consent, and data will be pseudonymized in accordance with GDPR. The study poses minimal risk, and participants will be monitored throughout treatment with adjustments made as needed.
This pilot study will generate essential data on treatment variability, feasibility, and preliminary outcomes of RMF orthosis use. The results will inform the design of a future randomized controlled trial and may contribute to improved evidence-based management of Boutonnière injuries, potentially leading to better functional outcomes and more efficient rehabilitation strategies.
Detailed description
Boutonnière injuries involve disruption of the central slip of the extensor tendon over the proximal interphalangeal (PIP) joint (zone III) of the finger. This leads to imbalance in the extensor mechanism, with volar displacement of the lateral bands and progressive development of Boutonnière deformity, characterized by PIP flexion and compensatory DIP hyperextension. Due to the often gradual onset and closed injury mechanism, diagnosis is frequently delayed. If untreated, the condition may result in stiffness, joint contractures, pain, reduced range of motion (ROM), and long-term functional impairment.
Current conservative treatment typically consists of prolonged immobilization of the PIP joint in extension, followed by dynamic orthotic management. Although widely used, evidence supporting existing treatment strategies is limited and outcomes are variable. Treatment is often demanding for patients due to prolonged splinting and restricted hand function during rehabilitation.
The Relative Motion Flexion (RMF) orthosis has been introduced as an alternative treatment strategy aimed at restoring balance within the extensor mechanism while allowing greater functional use of the hand during rehabilitation. However, current evidence is limited to small case series, heterogeneous cohorts, and studies with methodological limitations. Further prospective evaluation is therefore needed.
This study is designed as a prospective longitudinal pilot cohort study with repeated within-subject measurements. The primary purpose is to evaluate feasibility and to generate parameters required for planning a future randomized controlled trial, including estimates of variability in range of motion outcomes and within-subject correlations over time.
The study will also explore preliminary effects of RMF orthosis treatment on finger range of motion, as well as secondary outcomes including pain, grip strength, functional hand limitations, and patient-reported tolerability and adherence.
A total of 25 adult patients with acute or subacute closed central slip injuries (zone III) will be recruited consecutively at the Hand Surgery Rehabilitation Unit, Skåne University Hospital, Malmö, Sweden.
Participants will be treated with an RMF orthosis according to a structured rehabilitation protocol consisting of 6 weeks of continuous use followed by 6 weeks of intermittent use during daytime and nighttime. Treatment is delivered as part of routine rehabilitation follow-up, with adjustments made as clinically indicated.
Outcomes will be assessed at baseline, 3 months, and 12 months after treatment initiation. Primary outcome is range of motion (ROM) measured at the MCP, PIP, and DIP joints using a goniometer. Secondary outcomes include pain intensity (Numeric Rating Scale), grip strength (Jamar dynamometer), hand function (QuickDASH), and a study-specific questionnaire assessing adherence and tolerability. Recruitment rate will be recorded as number of eligible patients included per month.
As a pilot study, no control group is included. Analyses will focus on within-subject changes over time and estimation of parameters needed for sample size calculation in a future randomized controlled trial. Data will be analyzed using descriptive statistics and nonparametric longitudinal methods, including Friedman tests and Wilcoxon signed-rank tests for paired comparisons across time points.
The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval will be sought from the Swedish Ethical Review Authority (Etikprövningsmyndigheten). Written informed consent will be obtained from all participants. All data will be pseudonymized and handled in accordance with applicable data protection regulations (GDPR). The study involves minimal risk, and participants will be monitored throughout the rehabilitation period.
This pilot study will provide essential feasibility data and preliminary clinical outcomes for RMF orthosis treatment. The results will inform the design of a future randomized controlled trial and may contribute to improved evidence-based management of Boutonnière injuries, with the potential to enhance functional recovery and optimize rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- his is a single-group longitudinal pilot study with repeated within-subject measurements. All participants receive the same intervention (Relative Motion Flexion orthosis), and outcomes are assessed at multiple time points (baseline, 3 months, and 12 months) to evaluate changes over time. No control group is included; each participant serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Relative Motion Flexion (RMF) orthosis intervention group | Experimental | Other: Relative Motion Flexion (RMF) orthosis intervention groupParticipants in this arm receive treatment with a Relative Motion Flexion (RMF) orthosis as part of a structured rehabilitation protocol. The intervention consists of 6 weeks of continuous orthosis use followed by 6 weeks of intermittent use during daytime and nighttime. No control intervention is used, and outcomes are assessed longitudinally within the same participants over time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- persons with acute and subacute closed injurt to the central slip/extensor tendon zon 3
- positive pencil test
Key exclusion criteria (8 listed)
- open injury or infection
- joint contracture >20
- trauma >1 year ago
- previous trauma or surgery in the same finger
- simultaneous crush injury
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 |
|---|---|---|
| Relative Motion Flexion (RMF) orthosis intervention groupThe intervention consists of treatment with a Relative Motion Flexion (RMF) orthosis for patients with Boutonnière injuries of the finger (zone III extensor tendon injuries). The orthosis is applied according to a structured rehabilitation protocol consisting of 6 weeks of continuous wear, followed by 6 weeks of intermittent use during daytime and nighttime. The aim of the intervention is to restore extensor mechanism balance while allowing functional use of the hand during rehabilitation. Participants receive standard follow-up at the hand surgery rehabilitation unit, with adjustments made as clinically indicated. | Other | Relative Motion Flexion (RMF) orthosis intervention group |
Primary outcome
Range Of Motion (ROM)
Time frame: baseline, 3 months, 12 months
Range of Motion in each joint MCP, PIP, DIP
Range of motion (ROM)
Time frame: baseline, 3 months, 12 months
Active range of motion assessed with a finger goniometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 36202676Arslan OB, Sigirtmac IC, Ayvali C, Bas CE, Ayhan E, Bilgin SS, Oksuz C. The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. J Hand Surg Am. 2024 May;49(5):488.e1-488.e8. doi: 10.1016/j.jhsa.2022.08.007. Epub 2022 Oct 4.
- Background: PubMed 32028337Merritt WH, Jarrell K. A Paradigm Shift in Managing Acute and Chronic Boutonniere Deformity: Anatomic Rationale and Early Clinical Results for the Relative Motion Concept Permitting Immediate Active Motion and Hand Use. Ann Plast Surg. 2020 Mar;84(3S Suppl 2):S141-S150. doi: 10.1097/SAP.0000000000002307.
- Background: PubMed 31080073Johnson C, Swanson M, Manolopoulos K. Treatment of a zone III extensor tendon injury using a single relative motion with dorsal hood orthosis and a modified short arc motion protocol-A case report. J Hand Ther. 2021 Jan-Mar;34(1):135-141. doi: 10.1016/j.jht.2019.03.014. Epub 2019 May 10.
- Background: PubMed 32097332Merritt WH, Wong AL, Lalonde DH. Recent Developments Are Changing Extensor Tendon Management. Plast Reconstr Surg. 2020 Mar;145(3):617e-628e. doi: 10.1097/PRS.0000000000006556.
- Background: PubMed 31042102Geoghegan L, Wormald JCR, Adami RZ, Rodrigues JN. Central slip extensor tendon injuries: a systematic review of treatments. J Hand Surg Eur Vol. 2019 Oct;44(8):825-832. doi: 10.1177/1753193419845311. Epub 2019 May 1.
- Background: PubMed 29625636Fox PM, Chang J. Treating the Proximal Interphalangeal Joint in Swan Neck and Boutonniere Deformities. Hand Clin. 2018 May;34(2):167-176. doi: 10.1016/j.hcl.2017.12.006.
- Background: PubMed 37045641Merritt W. The relative motion concept in acute and chronic boutonniere deformity: Invited commentary. J Hand Ther. 2023 Apr-Jun;36(2):258-268. doi: 10.1016/j.jht.2023.02.005. Epub 2023 Apr 10.
- Background: PubMed 17013604Carl HD, Forst R, Schaller P. Results of primary extensor tendon repair in relation to the zone of injury and pre-operative outcome estimation. Arch Orthop Trauma Surg. 2007 Feb;127(2):115-9. doi: 10.1007/s00402-006-0233-3. Epub 2006 Sep 30.
- Background: PubMed 37085432van Strien G, van Zwieten KJ. An in-depth look at zone III and IV anatomy of the finger extensor mechanism and some clinical implications for use of the relative motion flexion orthosis. J Hand Ther. 2023 Apr-Jun;36(2):280-293. doi: 10.1016/j.jht.2023.01.002. Epub 2023 Apr 20.
- Individual participant dataSharing planned: No. IPD will not be publicly shared. De-identified data may be available upon reasonable request and ethical approval.
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.
Elisabeth Brogren, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relative Motion Flexion (RMF) orthosis intervention group in people with Finger Joint Deformities and Tendon Injuries, run by Lund University Hospital at 1 site in Sweden.
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 8 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrika Wijk, PhD (+46 40 331744, ulrika.wijk@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range Of Motion (ROM) (time frame: baseline, 3 months, 12 months). The study lists 2 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 NCT07921927, 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 6 Nov 2026.