Dataset Information

The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.

ABSTRACT:

Background

Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects.

Methods

The Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs.

Discussion

The goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges.

Trial registration

The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 . on February 14, 2017.

SUBMITTER: Sullivan JK

PROVIDER: S-EPMC6271417 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.

Sullivan James K JK Irrgang James J JJ Losina Elena E Safran-Norton Clare C Collins Jamie J Shrestha Swastina S Selzer Faith F Bennell Kim K Bisson Leslie L Chen Angela T AT Dawson Courtney K CK Gil Alexandra B AB Jones Morgan H MH Kluczynski Melissa A MA Lafferty Kathleen K Lange Jeffrey J Lape Emma C EC Leddy John J Mares Aaron V AV Spindler Kurt K Turczyk Jennifer J Katz Jeffrey N JN

BMC musculoskeletal disorders 20181201 1

<h4>Background</h4>Meniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects.<h4>Methods</h4>The Treatment of Meniscal Tear in Ost ...[more]

PMID: 30501629

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Project description:BackgroundMeniscal root tears cause menisci and their insertions to inadequately distribute loads and potentially leave underlying articular cartilage unprotected. Untreated meniscal root tears are becoming increasingly recognized to induce joint degradation; however, little information is known about anterior meniscal root tears and how they affect joint tissue.PurposeTo observe the early degenerative changes within the synovial fluid, menisci, tibial articular cartilage, and subchondral bone after arthroscopic creation of untreated anterior meniscal root tears.Study designControlled laboratory study.MethodsAnterolateral meniscal root tears were created in 1 knee joint of 5 adult Flemish Giant rabbits, and anteromedial meniscal root tears were created in 4 additional rabbits. The contralateral limbs were used as nonoperated controls. The animals were euthanized at 8 weeks postoperatively; synovial fluid was aspirated, and tissue samples of menisci and tibial articular cartilage were collected and processed for multiple analyses to detect signs of early degeneration.ResultsSignificant changes were found within the synovial fluid, meniscal tissue, and tibial subchondral bone of the knees with anterior meniscal root tears when compared with controls. There were no significant changes identified in the tibial articular cartilage when comparing the tear groups with controls.ConclusionThis study demonstrated early degenerative changes within the synovial fluid, menisci, and tibial subchondral bone when leaving anterior meniscal root tears untreated for 8 weeks. The results suggest that meniscal tissue presents measurable, degenerative changes prior to changes within the articular cartilage after anterior meniscal root tears. Anterior destabilization of the meniscus arthroscopically may lead to measurable degenerative changes and be useful for future in vivo natural history and animal repair studies.Clinical relevanceThe present study is the first to investigate various tissue changes after anterior meniscal root tears of both the medial and lateral menisci. The results from this study suggest that degenerative changes occur within the synovial fluid, meniscus, and tibial subchondral bone prior to any measurable changes to the tibial articular cartilage. Further studies should expand on this study to evaluate how these components continue to progress when left untreated for long periods.

Project description:BackgroundMeniscal tears are traditionally classified into traumatic versus degenerative tears. Although this classification plays a major role in clinical decision making, no consensus exists on the exact definition of a traumatic or degenerative tear, and the histopathological basis for this classification is unclear.PurposeTo assess the histological degree of meniscal degeneration in patients with a traumatic meniscal tear, as compared with intact meniscal tissue and osteoarthritic meniscal tissue.Study designDescriptive laboratory study.MethodsTraumatically torn meniscal tissue was collected during arthroscopic partial meniscectomy. As a control group, intact meniscal tissue was used from transfemoral amputations or direct postmortem dissections. Meniscal tissue from osteoarthritic knees was obtained during total knee replacement surgery. Meniscal tissue was processed, stained, and histologically analyzed with the Pauli scoring system (range, 0-18), comprising the subdomains surface integrity, cellularity, collagen organization, and matrix staining. Scoring was performed by 2 independent observers, blinded to condition, region, and patient data of the meniscus.ResultsThe traumatic meniscal tear group contained 43 patients (34 men; median age, 29 years; median body mass index [BMI], 24 kg/m2); the intact meniscal tissue group, 8 patients (3 men; median age, 58 years; median BMI, 30 kg/m2); and the osteoarthritic group, 14 patients (4 men; median age, 66 years; median BMI, 28 kg/m2). After adjustment for sex, age, and BMI, patients with a traumatic meniscal tear had a significantly higher histological score than patients with intact meniscal tissue (2.7-point difference; P = .035). Histological score between the traumatic and osteoarthritic groups was not different.ConclusionTraumatically torn menisci possess a higher degree of degeneration than intact menisci. Our results suggest that patients with a traumatic meniscal tear may already have had a certain degree of meniscal degeneration. These findings potentially challenge the classic view of traumatic versus degenerative meniscal tears.Clinical relevanceOur findings provide a better understanding of the tissue condition of a torn meniscus. This knowledge may help clinicians decide on choice of treatment and may lead to new perspectives to prevent knee osteoarthritis in patients with a torn meniscus.

Project description:Meniscal tearing in the knee increases the risk of post-traumatic osteoarthritis (OA) in patients. The therapeutic application of tissue-specific mesenchymal progenitor cells is currently being investigated as an emerging biologic strategy to help improve healing of musculoskeletal tissues like meniscal fibrocartilage and articular hyaline cartilage. However, many of these approaches involve isolating cells from healthy tissues, and the low yield of rare progenitor populations (< 1% of total cells residing in tissues) can make finding a readily available cell source for therapeutic use a significant logistical challenge. In the present study, we investigated the therapeutic efficacy of using expanded cartilage-derived and bone marrow-derived progenitor cell lines, which were stabilized using retroviral SV40, for repair of meniscus injury in a rodent model. Our findings indicate that these cell lines express the same cell surface marker phenotype of primary cells (CD54+, CD90+, CD105+, CD166+), and that they exhibit improved proliferative capacity that is suitable for extensive expansion. Skeletally mature male athymic rats treated with 3.2 million cartilage-derived progenitor cell line exhibited approximately 79% greater meniscal tear reintegration/healing, compared to injured animals that left untreated, and 76% greater compared to animals treated with the same number of marrow-derived stromal cells. Histological analysis of articular surfaces also showed that cartilage-derived progenitor cell line treated animals exhibited reduced post-traumatic OA associated articular cartilage degeneration. Stable cell line treatment did not cause tumor formation or off-target engraftment in animals. Taken together, we present a proof-of-concept study demonstrating, for the first time, that intra-articular injection of a stable human cartilage-derived progenitor cell line stimulates meniscus tear healing and provide chondroprotection in an animal model. These outcomes suggest that the use of stable cell lines may help overcome cell source limitations for cell-based medicine.

Dataset Information

The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.

Background

Methods

Discussion

Trial registration

Publications

The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.

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