Osteochondral Lesion of TalusNCT04132076
Treatment Outcome After Ankle Joint Surgeries
An observational study of Osteochondral Lesion of Talus and Ankle Arthritis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Osteochondral lesion of talus (OLT), osteoarthrosis and impingement/instability syndrome are most common ankle joint pathologies. This study analyses outcome after various different operative treatment of aforementioned pathologies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteochondral Lesion of Talus, Ankle Arthritis, Instability; Ankle (Ligaments) (Old Injury)
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 Apr 2019to Jan 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The invetigators will analyse cohort of patient after ankle joint surgery in the Department of Orthopaedic Surgery, UMC Ljubljana between 2008 and 2018.
Who may be able to join
- Patients with OLT treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- Patients with ankle joint osteoarthritis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
Who cannot join
- patient refuse to participate in study
- no respond of patient after invitation to answer a standardized questionnaire (EQ-5D, FAOS, Tegner activity score)
- no respond of patient after invitation to control examination after operation
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department of orthopaedic surgery, University medical centre Ljubljana
Ljubljana, 1000
About this study
Osteochondral lesion of talus (OLT), osteoarthrosis and impingement/instability syndrome are most common ankle joint pathologies. This study analyses outcome after various different operative treatment of aforementioned pathologies. Investigators hypothesis is that patient characteristics, type of lesion and surgical technique affect the result of treatment. The investigators will compare subjective (questionnaire) and objective (clinical examination) status of patient before and after operation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Osteochondral lesion of talus (OLT) | Patients with OLT treated operatively (debridement, microfracture, allograft, mesenchymal stem cells implantation) in Department of Orthopaedic Surgery, University Medical Centre Ljubljana (UMC). | |
| Group B: Ankle joint osteoarthrosis | Patients with ankle joint osteoarthrosis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. | |
| Group C: Ankle Impingement syndrome | Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. | |
| Group D: Ankle instability syndrome | Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAOS questionnaire
Foot and Ankle Outcome Score (FAOS) is a patient reported instrument that may be useful for assessing changes in foot/ankle pathology over time, with or without treatment. It assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
Measured: 36 months after operation
EQ-5D questionnaire
EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale used in the health state description part has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Measured: 36 months after operation
Tegner activity score
Tegner activity score is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity. The score varies from 0-10. A score of 0 represents sick leave or disability pension, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
Measured: 36 months after operation
Secondary outcomes (1)
Kellgren and Lawrence score
Kellgren and Lawrence score is a common method of classifying the severity of osteoarthritis (OA) using five grades.
grade 0: no radiographic features of OA are present grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
Measured: 36 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start17 Apr 2019
- Primary completionMar 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteochondral Lesion of TalusStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urban Brulc, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132076
- Sponsor's protocol ID
- 0120-99/2019/4
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kolar M, Brulc U, Strazar K, Drobnic M. Patient-reported joint status and quality of life in sports-related ankle disorders and osteoarthritis. Int Orthop. 2021 Apr;45(4):1049-1055. doi: 10.1007/s00264-020-04747-y. Epub 2020 Sep 17.
PubMed 32944803
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome After Ankle Joint Surgeries
- ClinicalTrials.gov ID
- NCT04132076
- Acronym / sponsor ID
- 0120-99/2019/4
- Conditions
- Osteochondral Lesion of Talus, Ankle Arthritis, Instability; Ankle (Ligaments) (Old Injury), Impingement Syndrome of Ankle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 18 Oct 2019 (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.
Osteochondral lesion of talus (OLT), osteoarthrosis and impingement/instability syndrome are most common ankle joint pathologies. This study analyses outcome after various different operative treatment of aforementioned pathologies. Investigators hypothesis is that patient characteristics, type of lesion and surgical technique affect the result of treatment. The investigators will compare subjective (questionnaire) and objective (clinical examination) status of patient before and after operation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Osteochondral lesion of talus (OLT) | – | –Patients with OLT treated operatively (debridement, microfracture, allograft, mesenchymal stem cells implantation) in Department of Orthopaedic Surgery, University Medical Centre Ljubljana (UMC). |
| Group B: Ankle joint osteoarthrosis | – | –Patients with ankle joint osteoarthrosis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. |
| Group C: Ankle Impingement syndrome | – | –Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. |
| Group D: Ankle instability syndrome | – | –Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The invetigators will analyse cohort of patient after ankle joint surgery in the Department of Orthopaedic Surgery, UMC Ljubljana between 2008 and 2018.
Key inclusion criteria (4 listed)
- Patients with OLT treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- Patients with ankle joint osteoarthritis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
- Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
Key exclusion criteria (3 listed)
- patient refuse to participate in study
- no respond of patient after invitation to answer a standardized questionnaire (EQ-5D, FAOS, Tegner activity score)
- no respond of patient after invitation to control examination after operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FAOS questionnaire
Time frame: 36 months after operation
Foot and Ankle Outcome Score (FAOS) is a patient reported instrument that may be useful for assessing changes in foot/ankle pathology over time, with or without treatment. It assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
EQ-5D questionnaire
Time frame: 36 months after operation
EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale used in the health state description part has three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Tegner activity score
Time frame: 36 months after operation
Tegner activity score is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity. The score varies from 0-10. A score of 0 represents sick leave or disability pension, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
1 secondary outcome
Kellgren and Lawrence score
Time frame: 36 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Derived from this study: PubMed 32944803Kolar M, Brulc U, Strazar K, Drobnic M. Patient-reported joint status and quality of life in sports-related ankle disorders and osteoarthritis. Int Orthop. 2021 Apr;45(4):1049-1055. doi: 10.1007/s00264-020-04747-y. Epub 2020 Sep 17.
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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.
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 Osteochondral Lesion of Talus and Ankle Arthritis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 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 18 Oct 2019. 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 Slovenia. 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?
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?
FAOS questionnaire (time frame: 36 months after operation). 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 NCT04132076, which also lists 1 linked publication.
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 2019.