Patient SatisfactionNCT04753424
Semitendinosus Graft as Meniscal Transplant
An observational study of Patient Satisfaction and Graft Failure, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. Different implants have been suggested to substitute a removed meniscus. Meniscal allograft transplantation is not widely available due to costs and availability. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Patient Satisfaction, Graft Failure, Osteo Arthritis Knee
- What is being tested?
- Surgical technique
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 1 Jan 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients, both male and female, 20-50 years of age, with previous subtotal or total meniscectomy, suffering from post meniscectomy symptoms are assessed at the outpatient clinic. If inclusion criteria are met, the patients receive information regarding the treatment.
Who may be able to join
- Previous subtotal or total meniscectomy
- Post meniscectomy symptoms
- No osteoarthritic changes on radiography more than Ahlbäck 1
- Knee aligment (hip-knee-angle) +/- 3°
- No persisting ACL insufficiency
Who cannot join
- Difficulty understanding the instructions
- Current psychiatric diagnosis
- Smoking
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
KISÖS
Stockholm, 11883
Karl Eriksson, prof, 0046707202646, karl.eriksson@ki.se
Erik Ronnblad, MD, 0046736785549, erik.ronnblad@ki.se
About this study
Official title: Autologous Semitendinosus Tendon Graft as Meniscal Transplant - a Clinical Pilot Study
Removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. Different implants have been suggested to substitute a removed meniscus. Meniscal allograft transplantation is not widely available due to costs and availability. The semitendinosus tendon is a known graft with biological properties with potential to remodel and revascularize in an intraarticular environment such as anterior cruciate ligament reconstruction. The objective for this study was to investigate whether the semitendinosus tendon graft could function as a meniscal transplant.
- Conditions
- Patient Satisfaction, Graft Failure, Osteo Arthritis Knee, ACL, Meniscus Tear
- Being tested
- Surgical technique
- Keywords
- meniscus transplantation
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical techniqueProcedure or surgery
Description of novel surgical technique using autologous semitendinosus graft as meniscus transplant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure
Surgical failure of transplant defined as meniscus symptoms (joint line tenderness, swelling, locking or positive McMurray) resulting in a need for re-arthroscopy and subtotal or total resection of the transplant.
Measured: 2 years
Secondary outcomes (4)
Improved subjective knee function
Patient reported outcome measure using the Knee Injury and Osteoarthritis Outcome Score (KOOS), 0-100 where 100 indicate best possible result.
Measured: 2 years
Improved subjective knee function
Patient reported outcome measure using Lysholm (0-100 where 100 indicate best possible result) and Tegner activity score (0-10, where 10 indicate the highest activity level) .
Measured: 2 years
Improved subjective knee function
Patient reported outcome measure using Euroqol 5 dimensions (EQ-5D) score (quality of life instrument with five dimensions with points from 1 to 3 where 1 indicates no problem and 3 indicate severe problems).
Measured: 2 years
Improved subjective knee function
Patient reported outcome measure using Global score (0-10 where 10 indicate best possible result)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl O. Eriksson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753424
- Sponsor's protocol ID
- semiTmeniscus
- Status last verified
- Jun 2022
- First submitted
- 6 Jan 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.
PubMed 8536007Johnson LL, Feagin JA Jr. Autogenous tendon graft substitution for absent knee joint meniscus: a pilot study. Arthroscopy. 2000 Mar;16(2):191-6. doi: 10.1016/s0749-8063(00)90035-5.
PubMed 10705332Ayala Mejias JD, Sciamanna RC, Muniesa MP, Perez-Espana LA. A case report of semitendinosus tendon autograft for reconstruction of the meniscal wall supporting a collagen implant. BMC Sports Sci Med Rehabil. 2013 Mar 28;5:4. doi: 10.1186/2052-1847-5-4.
PubMed 23557091
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Semitendinosus Tendon Graft as Meniscal Transplant - a Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT04753424
- Acronym / sponsor ID
- semiTmeniscus
- Conditions
- Patient Satisfaction, Graft Failure, Osteo Arthritis Knee, ACL, Meniscus Tear
- Keywords
- meniscus transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 15 Feb 2021 (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.
Removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. Different implants have been suggested to substitute a removed meniscus. Meniscal allograft transplantation is not widely available due to costs and availability. The semitendinosus tendon is a known graft with biological properties with potential to remodel and revascularize in an intraarticular environment such as anterior cruciate ligament reconstruction. The objective for this study was to investigate whether the semitendinosus tendon graft could function as a meniscal transplant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients, both male and female, 20-50 years of age, with previous subtotal or total meniscectomy, suffering from post meniscectomy symptoms are assessed at the outpatient clinic. If inclusion criteria are met, the patients receive information regarding the treatment.
Key inclusion criteria (5 listed)
- Previous subtotal or total meniscectomy
- Post meniscectomy symptoms
- No osteoarthritic changes on radiography more than Ahlbäck 1
- Knee aligment (hip-knee-angle) +/- 3°
- No persisting ACL insufficiency
Key exclusion criteria (3 listed)
- Difficulty understanding the instructions
- Current psychiatric diagnosis
- Smoking
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 |
|---|---|---|
| Surgical techniqueDescription of novel surgical technique using autologous semitendinosus graft as meniscus transplant. | Procedure or surgery | – |
Primary outcome
Failure
Time frame: 2 years
Surgical failure of transplant defined as meniscus symptoms (joint line tenderness, swelling, locking or positive McMurray) resulting in a need for re-arthroscopy and subtotal or total resection of the transplant.
4 secondary outcomes
Improved subjective knee function
Time frame: 2 years
Improved subjective knee function
Time frame: 2 years
Improved subjective knee function
Time frame: 2 years
Improved subjective knee function
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Background: PubMed 8536007Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.
- Background: PubMed 10705332Johnson LL, Feagin JA Jr. Autogenous tendon graft substitution for absent knee joint meniscus: a pilot study. Arthroscopy. 2000 Mar;16(2):191-6. doi: 10.1016/s0749-8063(00)90035-5.
- Background: PubMed 23557091Ayala Mejias JD, Sciamanna RC, Muniesa MP, Perez-Espana LA. A case report of semitendinosus tendon autograft for reconstruction of the meniscal wall supporting a collagen implant. BMC Sports Sci Med Rehabil. 2013 Mar 28;5:4. doi: 10.1186/2052-1847-5-4.
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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.
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 Patient Satisfaction and Graft Failure, run by Karolinska Institutet 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 5 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 23 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Eriksson, Prof (0046707202646, karl.eriksson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure (time frame: 2 years). 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 NCT04753424, which also lists 3 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 23 Jun 2022.