NCT04753424

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

6 years

First QC Date

January 6, 2021

Last Update Submit

June 22, 2022

Conditions

Patient SatisfactionGraft FailureOsteo Arthritis KneeACLMeniscus Tear

Keywords

meniscus transplantation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (4)

  • Improved subjective knee function

    2 years

  • Improved subjective knee function

    2 years

  • Improved subjective knee function

    2 years

  • Improved subjective knee function

    2 years

Interventions

Surgical techniquePROCEDURE

Description of novel surgical technique using autologous semitendinosus graft as meniscus transplant.

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Difficulty understanding the instructions
  • Current psychiatric diagnosis
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KISÖS

Stockholm, 11883, Sweden

RECRUITING

Related Publications (3)

  • Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. doi: 10.1007/BF01565466.

    PMID: 8536007BACKGROUND

  • Johnson 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.

    PMID: 10705332BACKGROUND

  • Ayala 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.

    PMID: 23557091BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Wound Closure Techniques

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Karl Eriksson, Prof

CONTACT

0046707202646karl.eriksson@ki.se

Erik Rönnblad, MD

CONTACT

0046736785549erik.ronnblad@ki.se

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2021

First Posted

February 15, 2021

Study Start

January 1, 2018

Primary Completion

January 1, 2024

Study Completion

January 1, 2026

Last Updated

June 23, 2022

Record last verified: 2022-06

Locations

SE(1)