Semitendinosus Graft as Meniscal Transplant

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee; Patient Satisfaction; ACL; Graft Failure; Meniscus Tear
• Intervention / Treatment: Procedure: Surgical technique

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Karl Eriksson, prof; Phone Number: 0046707202646; Email: karl.eriksson@ki.se
• Study Contact Backup: Name: Erik Ronnblad, MD; Phone Number: 0046736785549; Email: erik.ronnblad@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Recruiting
    • KISÖS
    • Contact: Karl Eriksson, prof; Phone Number: 0046707202646; Email: karl.eriksson@ki.se
    • Contact: Erik Ronnblad, MD; Phone Number: 0046736785549; Email: erik.ronnblad@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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) .	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).	2 years
Improved subjective knee function	Patient reported outcome measure using Global score (0-10 where 10 indicate best possible result)	2 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2026

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: meniscus transplantation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: semiTmeniscus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No