Semitendinosus Graft as Meniscal Transplant

NCT ID: NCT04753424

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Satisfaction Graft Failure Osteo Arthritis Knee ACL Meniscus Tear

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Surgical technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Difficulty understanding the instructions
* Current psychiatric diagnosis
* Smoking
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Karl O. Eriksson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KISÖS

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Karl Eriksson, Prof

Role: CONTACT

0046707202646

Erik Rönnblad, MD

Role: CONTACT

0046736785549

Facility Contacts

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Karl Eriksson, prof

Role: primary

0046707202646

Erik Ronnblad, MD

Role: backup

0046736785549

References

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

Reference Type BACKGROUND
PMID: 8536007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10705332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23557091 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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semiTmeniscus

Identifier Type: -

Identifier Source: org_study_id

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