Semitendinosus Graft as Meniscal Transplant

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT04753424
Collaborator
(none)
10
1
96
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical technique

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Autologous Semitendinosus Tendon Graft as Meniscal Transplant - a Clinical Pilot Study
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Failure [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.

Secondary Outcome Measures

  1. Improved subjective knee function [2 years]

    Patient reported outcome measure using the Knee Injury and Osteoarthritis Outcome Score (KOOS), 0-100 where 100 indicate best possible result.

  2. Improved subjective knee function [2 years]

    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) .

  3. Improved subjective knee function [2 years]

    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).

  4. Improved subjective knee function [2 years]

    Patient reported outcome measure using Global score (0-10 where 10 indicate best possible result)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KISÖS Stockholm Sweden 11883

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Karl O. Eriksson, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04753424
Other Study ID Numbers:
  • semiTmeniscus
First Posted:
Feb 15, 2021
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karl O. Eriksson, Associate Professor, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2022