Semitendinosus Graft as Meniscal Transplant

Patient Satisfaction Clinical Trial

Official title:

Autologous Semitendinosus Tendon Graft as Meniscal Transplant - a Clinical Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753424
• Other study ID #: semiTmeniscus
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2022
• Source: Karolinska Institutet
• Contact: Karl Eriksson, Prof
• Phone: 0046707202646
• Email: karl.eriksson[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL
• Graft Failure
• Meniscus Tear
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Patient Satisfaction

Intervention

Procedure:
• Surgical technique
Description of novel surgical technique using autologous semitendinosus graft as meniscus transplant.

Locations

Country	Name	City	State
Sweden	KISÖS	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Ayala Mejias JD, Sciamanna RC, Muniesa MP, Pérez-España 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. — View Citation

Johnson LL, Feagin JA Jr. Autogenous tendon graft substitution for absent knee joint meniscus: a pilot study. Arthroscopy. 2000 Mar;16(2):191-6. — View Citation

Kohn D. Autograft meniscus replacement: experimental and clinical results. Knee Surg Sports Traumatol Arthrosc. 1993;1(2):123-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Improved subjective knee function	Patient reported outcome measure using Global score (0-10 where 10 indicate best possible result)	2 years