Semitendinosus Graft as Meniscal Transplant

Recruiting

• Conditions: Patient Satisfaction; Osteo Arthritis Knee; Meniscus Tear; Graft Failure; ACL

• Registration Number: NCT04753424
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23
• Primary Completion: 2024-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

• Difficulty understanding the instructions
• Current psychiatric diagnosis
• Smoking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improved subjective knee function	2 years	Patient reported outcome measure using Global score (0-10 where 10 indicate best possible result)

Trial Locations

Locations (1)

KISÖS; 🇸🇪 Stockholm, Sweden