FractureNCT05580848
Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures
A study testing Wrist arthroscopy in people with Fracture and Radius Fracture Distal, run by Clinic for Orthopedics Lovran.
Trial summary
Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Fracture, Radius Fracture Distal
- What is being tested?
- Wrist arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2022to 20 Sep 2024
- 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 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fractures with an indication for surgical treatment according to the AO/OTA classification of patients aged 50-69 years who have signed an informed consent to participate in the research.
Who cannot join
- Distal radius fractures( DRF) that have an indication for surgical treatment in all patients and in patients younger than 50 and older than 69,
- DRF that do not have an indication for surgical treatment,
- Refusal to participate in the research,
- Inability to decide independently about participation in the research (persons under guardianship),
- Open fractures,
- Presence of severe soft tissue injuries,
- Infections,
- Poor general condition of patients and internal medicine contraindications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures Improves Functional Outcome: a Randomized Controlled Trial
Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results.
Objectives of the study: (1) Validate wrist functional outcome questionnaires; (2) To determine whether arthroscopically assisted repositioning of fracture fragments in articular DRFs leads to a better treatment outcome; (3) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular DRFs leads to a better treatment outcome; (4) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular DRFs leads to a better treatment outcome.
Read more
Research hypotheses: (1) Validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a WA randomized controlled trial; (2) WA as an adjunct to DRF osteosynthesis improves the clinical outcome of treatment.
Subjects: 56 female patients with indication for DRF osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) with associated WA, and 2. control - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) without associated WA.
Methods: As a primary outcome measure, functional outcomes of treatment will be analyzed with the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 6 months after surgery. As a secondary outcome measures it will be analyzed pain level according to a visual analog scale (VAS), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the Mayo Wrist Score (MWS) and Patient-Rated Wrist Evaluation (PRWE) score at 3 and 6 months after surgery. Expected scientific contribution: providing answers on the role of WA in the treatment of DRF and associated injuries as well as its impact on treatment outcome.
- Conditions
- Fracture, Radius Fracture Distal
- Being tested
- Wrist arthroscopy
- Keywords
- Arthroscopy, Radius Fractures, Surveys and Questionnaires, Treatment Outcome, Wrist
- Medical subject headings
- Fractures, Bone, Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist arthroscopyProcedure or surgery
Wrist arthroscopy is a minimally invasive endoscopic method that enables the diagnosis and treatment of certain diseases and injuries of the radiocarpal, mediocarpal and distal radioulnar joints.
Wrist arthroscopy enables a direct view of the articular surface of the wrist and the assessment and adequate treatment of articular fractures The wrist arthroscopy procedure also enables the detection and necessary treatment of associated soft tissue injuries (scapho-lunate and/or luno-triquetral ligament, i.e. triangular fibrocartilaginous complex) and/or cartilage lesions in extra-articular and articular fractures.
| Study group | Role | What they receive |
|---|---|---|
| Examined group | Experimental | 28 patients with indication for distal radius fracture (DRF) osteosynthesis : 14 patients with extraarticular DRF and 14 patients with intraarticular DRF with associated wrist arthroscopy Receives: Procedure: Wrist arthroscopy |
| Control group | No intervention | 28 patients with indication for distal radius fracture (DRF) osteosynthesis : 14 patients with extraarticular DRF and 14 patients with intraarticular DRF without associated wrist arthroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH Score
Disabilities of the Arm, Shoulder and Hand It consists of 30 questions and is used to assess functional disorders of the upper extremity. 21 questions examine the extent to which the patient had problems performing certain activities during the last week. 6 questions assess specific symptoms (eg, pain, paresthesias, sleep disturbances) during the last week, and 3 questions assess social or occupational limitations during the last week. The possible score ranges from 0 to 100 points. 0 points represents complete, unrestricted function of the upper extremities, while 100 points represents the greatest possible functional impairment.
Measured: 3 months after surgery
DASH Score
Disabilities of the Arm, Shoulder and Hand It consists of 30 questions and is used to assess functional disorders of the upper extremity. 21 questions examine the extent to which the patient had problems performing certain activities during the last week. 6 questions assess specific symptoms (eg, pain, paresthesias, sleep disturbances) during the last week, and 3 questions assess social or occupational limitations during the last week. The possible score ranges from 0 to 100 points. 0 points represents complete, unrestricted function of the upper extremities, while 100 points represents the greatest possible functional impairment.
Measured: 6 months after surgery
Secondary outcomes (6)
VAS
The visual analogue scale (VAS) of pain will be used in this study as a tool to assess the clinical outcome of treatment. It consists of the length of a solid line with values at the beginning and end of the line from 0 to 10 cm (0 - 100 mm). The leftmost side means the absence of pain, and the rightmost side means unbearable pain.
Measured: 3 months after surgery.
VAS
The visual analogue scale (VAS) of pain will be used in this study as a tool to assess the clinical outcome of treatment. It consists of the length of a solid line with values at the beginning and end of the line from 0 to 10 cm (0 - 100 mm). The leftmost side means the absence of pain, and the rightmost side means unbearable pain.
Measured: 6 months after surgery.
MWS
The Mayo Wrist Score (MWS) will be evaluated through 4 questions: (1) pain intensity, (2) functional status - ability to return to regular work, (3) active range of motion of bending /extension of the affected wrist compared to the contralateral side (5 answers offered to be scored from 0 to 25 points) and (4) grip strength of the affected hand compared to the contralateral side (5 answers offered to be scored from 0 to 25 points). The possible score ranges from 0 to 100 points. Interpretation of the results: from 90-100 points is an excellent result, 80-90 points is a good result, 60-80 points is a satisfactory result, and below 60 points is a bad result.
Measured: 3 months after surgery.
MWS
The Mayo Wrist Score (MWS) will be evaluated through 4 questions: (1) pain intensity, (2) functional status - ability to return to regular work, (3) active range of motion of bending /extension of the affected wrist compared to the contralateral side (5 answers offered to be scored from 0 to 25 points) and (4) grip strength of the affected hand compared to the contralateral side (5 answers offered to be scored from 0 to 25 points). The possible score ranges from 0 to 100 points. Interpretation of the results: from 90-100 points is an excellent result, 80-90 points is a good result, 60-80 points is a satisfactory result, and below 60 points is a bad result.
Measured: 6 months after surgery.
PRWE
The Patient-Rated Wrist Evaluation (PRWE) score is a highly reliable and valid 15-question questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to assess their own level of pain and disability in the wrist from 0 to 10, and consists of 2 parts: pain and function. The part about pain contains 5 questions, the maximum score in this part is 50, and the minimum is 0. The part about function contains 10 questions divided into 2 parts, i.e. specific activities (6 questions) and usual activities (4 questions). The maximum score in this part is 50, and the minimum is 0.
Measured: 3 months after surgery.
PRWE
The Patient-Rated Wrist Evaluation (PRWE) score is a highly reliable and valid 15-question questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to assess their own level of pain and disability in the wrist from 0 to 10, and consists of 2 parts: pain and function. The part about pain contains 5 questions, the maximum score in this part is 50, and the minimum is 0. The part about function contains 10 questions divided into 2 parts, i.e. specific activities (6 questions) and usual activities (4 questions). The maximum score in this part is 50, and the minimum is 0.
Measured: 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start20 Nov 2022 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinic for Orthopedics Lovran
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka
- Responsible party
- Principal investigator, Borjan Josifovski, Clinic for Orthopedics Lovran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580848
- Sponsor's protocol ID
- ClinicOL
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
PubMed 16814787Rundgren J, Bojan A, Mellstrand Navarro C, Enocson A. Epidemiology, classification, treatment and mortality of distal radius fractures in adults: an observational study of 23,394 fractures from the national Swedish fracture register. BMC Musculoskelet Disord. 2020 Feb 8;21(1):88. doi: 10.1186/s12891-020-3097-8.
PubMed 32035488Ochen Y, Peek J, van der Velde D, Beeres FJP, van Heijl M, Groenwold RHH, Houwert RM, Heng M. Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Apr 1;3(4):e203497. doi: 10.1001/jamanetworkopen.2020.3497.
PubMed 32324239Song J, Yu AX, Li ZH. Comparison of conservative and operative treatment for distal radius fracture: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015 Oct 15;8(10):17023-35. eCollection 2015.
PubMed 26770293Ju JH, Jin GZ, Li GX, Hu HY, Hou RX. Comparison of treatment outcomes between nonsurgical and surgical treatment of distal radius fracture in elderly: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Oct;400(7):767-79. doi: 10.1007/s00423-015-1324-9. Epub 2015 Aug 30.
PubMed 26318178Chen Y, Chen X, Li Z, Yan H, Zhou F, Gao W. Safety and Efficacy of Operative Versus Nonsurgical Management of Distal Radius Fractures in Elderly Patients: A Systematic Review and Meta-analysis. J Hand Surg Am. 2016 Mar;41(3):404-13. doi: 10.1016/j.jhsa.2015.12.008. Epub 2016 Jan 20.
PubMed 26810824Armstrong KA, von Schroeder HP, Baxter NN, Zhong T, Huang A, McCabe SJ. Stable rates of operative treatment of distal radius fractures in Ontario, Canada: a population-based retrospective cohort study (2004-2013). Can J Surg. 2019 Dec 1;62(6):386-392. doi: 10.1503/cjs.016218.
PubMed 31782295Mauck BM, Swigler CW. Evidence-Based Review of Distal Radius Fractures. Orthop Clin North Am. 2018 Apr;49(2):211-222. doi: 10.1016/j.ocl.2017.12.001.
PubMed 29499822Cazzola M, Bergamaschi G, Melazzini M, Ponchio L, Rosti V, Molinari E. Chronic myelogenous leukemia following radiotherapy and chemotherapy for non-Hodgkin lymphoma. Haematologica. 1990 Sep-Oct;75(5):477-9.
PubMed 2097266Baron JA, Karagas M, Barrett J, Kniffin W, Malenka D, Mayor M, Keller RB. Basic epidemiology of fractures of the upper and lower limb among Americans over 65 years of age. Epidemiology. 1996 Nov;7(6):612-8. doi: 10.1097/00001648-199611000-00008.
PubMed 8899387Brogren E, Petranek M, Atroshi I. Incidence and characteristics of distal radius fractures in a southern Swedish region. BMC Musculoskelet Disord. 2007 May 31;8:48. doi: 10.1186/1471-2474-8-48.
PubMed 17540030Mellstrand-Navarro C, Pettersson HJ, Tornqvist H, Ponzer S. The operative treatment of fractures of the distal radius is increasing: results from a nationwide Swedish study. Bone Joint J. 2014 Jul;96-B(7):963-9. doi: 10.1302/0301-620X.96B7.33149.
PubMed 24986952Stirling ERB, Johnson NA, Dias JJ. Epidemiology of distal radius fractures in a geographically defined adult population. J Hand Surg Eur Vol. 2018 Nov;43(9):974-982. doi: 10.1177/1753193418786378. Epub 2018 Jul 17.
PubMed 30016904Solvang HW, Nordheggen RA, Clementsen S, Hammer OL, Randsborg PH. Epidemiology of distal radius fracture in Akershus, Norway, in 2010-2011. J Orthop Surg Res. 2018 Aug 13;13(1):199. doi: 10.1186/s13018-018-0904-0.
PubMed 30103788Whipple TL. The role of arthroscopy in the treatment of intra-articular wrist fractures. Hand Clin. 1995 Feb;11(1):13-8.
PubMed 7751326
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures Improves Functional Outcome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05580848
- Acronym / sponsor ID
- ClinicOL
- Conditions
- Fracture, Radius Fracture Distal
- Keywords
- Arthroscopy, Radius Fractures, Surveys and Questionnaires, Treatment Outcome, Wrist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Clinic for Orthopedics LovranUniversity, hospital or other
- Collaborators
- University of Rijeka
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 14 Oct 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.
Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results.
Objectives of the study: (1) Validate wrist functional outcome questionnaires; (2) To determine whether arthroscopically assisted repositioning of fracture fragments in articular DRFs leads to a better treatment outcome; (3) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular DRFs leads to a better treatment outcome; (4) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular DRFs leads to a better treatment outcome.
Research hypotheses: (1) Validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a WA randomized controlled trial; (2) WA as an adjunct to DRF osteosynthesis improves the clinical outcome of treatment.
Subjects: 56 female patients with indication for DRF osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) with associated WA, and 2. control - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) without associated WA.
Methods: As a primary outcome measure, functional outcomes of treatment will be analyzed with the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 6 months after surgery. As a secondary outcome measures it will be analyzed pain level according to a visual analog scale (VAS), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the Mayo Wrist Score (MWS) and Patient-Rated Wrist Evaluation (PRWE) score at 3 and 6 months after surgery. Expected scientific contribution: providing answers on the role of WA in the treatment of DRF and associated injuries as well as its impact on treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Examined group | Experimental | Procedure: Wrist arthroscopy28 patients with indication for distal radius fracture (DRF) osteosynthesis : 14 patients with extraarticular DRF and 14 patients with intraarticular DRF with associated wrist arthroscopy |
| Control group | No intervention | –28 patients with indication for distal radius fracture (DRF) osteosynthesis : 14 patients with extraarticular DRF and 14 patients with intraarticular DRF without associated wrist arthroscopy. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Distal radius fractures with an indication for surgical treatment according to the AO/OTA classification of patients aged 50-69 years who have signed an informed consent to participate in the research.
Key exclusion criteria (8 listed)
- Distal radius fractures( DRF) that have an indication for surgical treatment in all patients and in patients younger than 50 and older than 69,
- DRF that do not have an indication for surgical treatment,
- Refusal to participate in the research,
- Inability to decide independently about participation in the research (persons under guardianship),
- Open fractures,
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 |
|---|---|---|
| Wrist arthroscopyWrist arthroscopy is a minimally invasive endoscopic method that enables the diagnosis and treatment of certain diseases and injuries of the radiocarpal, mediocarpal and distal radioulnar joints. Wrist arthroscopy enables a direct view of the articular surface of the wrist and the assessment and adequate treatment of articular fractures The wrist arthroscopy procedure also enables the detection and necessary treatment of associated soft tissue injuries (scapho-lunate and/or luno-triquetral ligament, i.e. triangular fibrocartilaginous complex) and/or cartilage lesions in extra-articular and articular fractures. | Procedure or surgery | Examined group |
Primary outcome
DASH Score
Time frame: 3 months after surgery
Disabilities of the Arm, Shoulder and Hand It consists of 30 questions and is used to assess functional disorders of the upper extremity. 21 questions examine the extent to which the patient had problems performing certain activities during the last week. 6 questions assess specific symptoms (eg, pain, paresthesias, sleep disturbances) during the last week, and 3 questions assess social or occupational limitations during the last week. The possible score ranges from 0 to 100 points. 0 points represents complete, unrestricted function of the upper extremities, while 100 points represents the greatest possible functional impairment.
DASH Score
Time frame: 6 months after surgery
Disabilities of the Arm, Shoulder and Hand It consists of 30 questions and is used to assess functional disorders of the upper extremity. 21 questions examine the extent to which the patient had problems performing certain activities during the last week. 6 questions assess specific symptoms (eg, pain, paresthesias, sleep disturbances) during the last week, and 3 questions assess social or occupational limitations during the last week. The possible score ranges from 0 to 100 points. 0 points represents complete, unrestricted function of the upper extremities, while 100 points represents the greatest possible functional impairment.
6 secondary outcomes
VAS
Time frame: 3 months after surgery.
VAS
Time frame: 6 months after surgery.
MWS
Time frame: 3 months after surgery.
MWS
Time frame: 6 months after surgery.
PRWE
Time frame: 3 months after surgery.
PRWE
Time frame: 6 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 16814787Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
- Background: PubMed 32035488Rundgren J, Bojan A, Mellstrand Navarro C, Enocson A. Epidemiology, classification, treatment and mortality of distal radius fractures in adults: an observational study of 23,394 fractures from the national Swedish fracture register. BMC Musculoskelet Disord. 2020 Feb 8;21(1):88. doi: 10.1186/s12891-020-3097-8.
- Background: PubMed 32324239Ochen Y, Peek J, van der Velde D, Beeres FJP, van Heijl M, Groenwold RHH, Houwert RM, Heng M. Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Apr 1;3(4):e203497. doi: 10.1001/jamanetworkopen.2020.3497.
- Background: PubMed 26770293Song J, Yu AX, Li ZH. Comparison of conservative and operative treatment for distal radius fracture: a meta-analysis of randomized controlled trials. Int J Clin Exp Med. 2015 Oct 15;8(10):17023-35. eCollection 2015.
- Background: PubMed 26318178Ju JH, Jin GZ, Li GX, Hu HY, Hou RX. Comparison of treatment outcomes between nonsurgical and surgical treatment of distal radius fracture in elderly: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Oct;400(7):767-79. doi: 10.1007/s00423-015-1324-9. Epub 2015 Aug 30.
- Background: PubMed 26810824Chen Y, Chen X, Li Z, Yan H, Zhou F, Gao W. Safety and Efficacy of Operative Versus Nonsurgical Management of Distal Radius Fractures in Elderly Patients: A Systematic Review and Meta-analysis. J Hand Surg Am. 2016 Mar;41(3):404-13. doi: 10.1016/j.jhsa.2015.12.008. Epub 2016 Jan 20.
- Background: PubMed 31782295Armstrong KA, von Schroeder HP, Baxter NN, Zhong T, Huang A, McCabe SJ. Stable rates of operative treatment of distal radius fractures in Ontario, Canada: a population-based retrospective cohort study (2004-2013). Can J Surg. 2019 Dec 1;62(6):386-392. doi: 10.1503/cjs.016218.
- Background: PubMed 29499822Mauck BM, Swigler CW. Evidence-Based Review of Distal Radius Fractures. Orthop Clin North Am. 2018 Apr;49(2):211-222. doi: 10.1016/j.ocl.2017.12.001.
- Background: PubMed 2097266Cazzola M, Bergamaschi G, Melazzini M, Ponchio L, Rosti V, Molinari E. Chronic myelogenous leukemia following radiotherapy and chemotherapy for non-Hodgkin lymphoma. Haematologica. 1990 Sep-Oct;75(5):477-9.
- Background: PubMed 8899387Baron JA, Karagas M, Barrett J, Kniffin W, Malenka D, Mayor M, Keller RB. Basic epidemiology of fractures of the upper and lower limb among Americans over 65 years of age. Epidemiology. 1996 Nov;7(6):612-8. doi: 10.1097/00001648-199611000-00008.
- Background: PubMed 17540030Brogren E, Petranek M, Atroshi I. Incidence and characteristics of distal radius fractures in a southern Swedish region. BMC Musculoskelet Disord. 2007 May 31;8:48. doi: 10.1186/1471-2474-8-48.
- Background: PubMed 24986952Mellstrand-Navarro C, Pettersson HJ, Tornqvist H, Ponzer S. The operative treatment of fractures of the distal radius is increasing: results from a nationwide Swedish study. Bone Joint J. 2014 Jul;96-B(7):963-9. doi: 10.1302/0301-620X.96B7.33149.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist arthroscopy in people with Fracture and Radius Fracture Distal, run by Clinic for Orthopedics Lovran.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 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?
Contact Borjan Josifovski, MD (+385911542647, borjan.josifovski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH Score (time frame: 3 months after surgery). 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 NCT05580848, which also lists 33 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 18 Oct 2022.